Phakic Intraocular Lenses Survey

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Phakic Intraocular Lenses

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SURVEY OF OPHTHALMOLOGY
VOLUME 50 NUMBER 6 NOVEMBERDECEMBER 2005
DIAGNOSTIC AND SURGICAL

TECHNIQUES
MARCO ZARBIN AND DAVID CHU, EDITORS
Phakic Intraocular Lenses

Carlo F. Lovisolo, MD,1 and Dan Z. Reinstein, MD, MA (Cantab), FRCSC, DABO2,3
1
2
Department of Ophthalmology and Visual Sciences, San Raffaele Hospital and QuattroElle Eye Center, Milan, Italy;
London Vision Clinic, London; and 3Department of Ophthalmology, St. Thomas Hospital-Kings College, London, UK
Abstract. An analytical review of the data available in the field of phakic intraocular lens implantation
was conducted. Particular attention was paid to the more critical issues of intraocular lens sizing and
safety guidelines. A comprehensive, competitive analysis of different implantation sites, intraocular
lens model designs, and safety guidelines has been included. Specialized biometry techniques, such as
very high frequency ultrasound and Scheimpflug imaging, have been reviewed, and a critical review of
commercial claims regarding intraocular lens technologies has been included. Clinical studies of
phakic intraocular lenses demonstrate increasing promise for the correction of refractive errors not
amenable to mainstream excimer laser refractive surgery. The main issues currently revolve around
adequate lens design (VHF ultrasound study suggests that custom-design and sizing may be the most
effective and safest approach for every phakic IOL model), because these devices will be required to
remain physiologically inert and anatomically compatible with internal ocular structures and relations
for several decades. The possibility of safe removing or exchanging the IOL should remain a feasible
option over time. It is of utmost importance that we continue to critically evaluate current encouraging
short-term outcomes, which are being extrapolated to the longer term by ongoing high resolution
imaging and monitoring of the anatomical and functional relations of implanted phakic IOLs. (Surv
Ophthalmol 50:549--587, 2005. 2005 Elsevier Inc. All rights reserved.)
Key words. high myopia (surgery) hyperopia (surgery) lens implantation intraocular
phakic IOL phakic intraocular lens refractive IOL refractive surgery
image quality. Because the cornea is responsible for

about three-quarters of the total focusing power of
the eye, even small alterations to its anterior surface
can be used to modify ocular refraction to correct
a large proportion of the ammetropias. This has been
successfully achieved by sculpting methods afforded
by the excimer laser (LASIK, PRK, or LASEK) as well
as a number of mechanically based procedures, such
as incisional, thermal, and additive techniques.
Introduction
The surgical solutions to correct refractive errors
exploit three anatomical possibilities, and each is
highlighted below.
First, the corneal lens of the eye has an excellent
life-long stability, because its natural prolate architecture has evolved to deliver very high vergence, while
minimizing optical aberrations, to provide excellent
549
2005 by Elsevier Inc.
All rights reserved.
0039-6257/05/$--see front matter

doi:10.1016/j.survophthal.2005.08.011
550
Surv Ophthalmol 50 (6) November--December 2005
Corneal procedures are subject to challengingalthough now less commonsurgical complications, and
to issues relating to wound healing and biomechanics, both of which will influence the precision and
stability of the results.182 The optical quality of the
outcomes can be less than ideal when treating high
ammetropias and patients with large mesopic pupil
sizes20,173 due to inadequate optical zone dimensions
and centration, excessive corneal flattening or
steepening, as well as unwanted surface microirregularities. Highly sophisticated optimized and
customized laser based treatments are beginning to
provide ablations that minimize the induction of
higher order aberrations, but physical limitations of
corneal thickness as well as biomechanical behavior
will limit the ability to maintain the minimal
aberrational structure of the physiological cornea,214
particularly in high ammetropic eyes.
Second, the crystalline lens affects one-fourth of the
refractive power of the eyes optical system. It grows
and becomes sclerotic throughout life, causing
changes of refraction and presbyopia.108,257 Preliminary evidence has shown that modern, minimally
invasive clear lens extraction (CLE)109,112 plus toric,
piggy-back,79,130 aspheric,131 multifocal, or accommodating23,79,154,160,177,183 IOL implantation can be
considered sufficiently effective, predictable, and
stable. However, as multifocal optics decrease contrast
sensitivity and much doubtful data do not allow us, yet,
to consider accommodating IOLs as a valid dynamic
substitute for the natural lens, CLE causes loss of
accommodation in young people. Long-term safety is
also a concern, due to the risk of retinal detachment
and maculopathy in eyes naturally prone to posterior
segment pathology (i.e., high myopia).32,66,98,109
Third, a supplementary IOL (phakic IOL) implanted between the cornea and the lens, fixated in
the angle, enclavated to the mid-peripheral iris with
a claw or placed in the posterior chamber, gives rise
to a condition called duophakia or artiphakia111 and
has several advantages:165
1) It allows the crystalline lens to retain its function and may possibly protect against vitreoretinal side effects of CLE
2) Because the quality of the lens implant surfaces
is above the optical limits of the eye, its nodal
points are nearer the pupil and the optic (especially with the newest materials and designs) can
be conveniently wide, it maintains and potentially could even improve the natural properties
of the eyes optical system to enhance the quality
of the retinal image, allowing excellent vision
even in dim light conditions.54,120,127,129 PostLASIK eyes have been found to yield two to
three times more spherical aberration and coma
LOVISOLO AND REINSTEIN
than eyes implanted with a posterior chamber

collamer phakic IOL (ICL)226
3) The lens is removable and exchangeable,
permitting potential reversibility to the preoperative condition134,241
4) The result is predictable,4,13,18,36,72,77,113,156,157,
175,194,202,218,243,247,250,263
easily adjustable with
complementary fine-tuning corneal surgeries,19,115,219,261 and immediately stable, because
the refractive outcome depends less on healing
processes
The drawbacks of phakic IOLs are related to the
risks of an intraocular operative procedure. Although extremely rare, catastrophic complications
with irreversible, severe iatrogenic damage to the
delicate inner structures are possible, and the
potential consequences of the surgical opening of
the eye with decompression of the anterior chamber
in uneventful procedures is an issue that still requires to be thoroughly addressed.163 Once inside
the eye and over time, each site of haptic fixation
has its own area of unique concern. Angle-fixated
IOLs stay in contact with peripheral iris and
chamber angle structures. Iris-supported lenses
pinch the mid-peripheral iris tissue. They can
potentially induce acute and recurrent subchronic
iritis, ischemic subatrophy of the iris, pupil distortion, progressive endothelial cell loss, secondary
glaucoma, and alteration of the blood/aqueous
barrier with persistent aqueous flare and cystoid
macular edema.10,41,105,141,178,197,198,199,225,251
Posterior chamber phakic IOLs are vaulted
between the posterior pigmented layers of the
iris and the anterior crystalline lens with the
anterior zonules. They may cause angle closure
and malignant glaucoma, ischemic blown pupil
(Urrets-Zavalia syndrome), cataract, chafing of the
posterior iris and ciliary processes with pigmentary
dispersion syndrome, damage to the zonules with
dislocation of the IOL in the vitreous, cyclitis,
chronic uveal inflammation, and macular
edema.2,46,52,73,83,97,147,150,220,221,246,252
Historical Overview
ANTERIOR CHAMBER PHAKIC LENSES (ACP-IOLS)
Angle-Fixated Lenses
The irido-corneal angle was chosen by Dannheim,69 Baron,30,31 and Strampelli236 in the early
1950s as the first, easy-to-maneuver anatomical space
reached by the surgeon for inserting a lens into
a phakic eye. The frequent corneal decompensation
of Barons early polymethylmethacrylate (PMMA)
lens (1952), originally designed to float in the
PHAKIC INTRAOCULAR LENSES
anterior chamber, led him to conclude that fixation points would be required to maintain the
implant in situ. The model designed by Strampelli,
the prototype for an entire generation of IOLs
(Fig. 1),47,236 had a tripod shape with three points to
be fixated in the chamber angle. The trailing haptic
was swallow-tailed to facilitate iridectomy at the end
of the operation. To calculate the power of the lens,
the same spectacle power was chosen for a meniscus
optic of 6.0 mm and an overall length of 11--12 mm.
After several years of anecdotal reports by European
pioneers who adopted this model with small further
changes,35,47,60,168 Barraquer,34 in 1959, reported
the first statistically significant study on 239 anglefixated phakic IOLs followed up for 5 years.33 Since
then, the correct choice of the overall length of the
lens appeared particularly critical, as the haptics
were not flexible enough to accommodate angle
diameters smaller than the implant overall length.
Even a slightly longer implant caused undue
pressure with angle recession, intraocular pressure
rise, and hyphema because of erosion of goniostructures, low-grade recurrent inflammation with
anterior synechiae, pupil distortion, and sectorial
atrophy of the iris. On the other hand, while the
crucial role of the endothelium in preserving
corneal transparency was poorly understood, too
short a lens caused undesired movements with
progressive endothelial cell loss secondary to intermittent contact with corneal inner layers, and iris
chafing. The optic became decentered, causing
visual symptoms. More than 60% of the implants
had to be removed because of disastrous consequences such as corneal decompensation or what
Fig. 1. Artists remake, from the original drawings, of the

Strampelli anterior chamber phakic IOL for myopia.
(Reprinted from Lovisolo and Pesando165 with permission
of Fabiano Editore.)
551
was subsequently called the UGH-syndrome (uveitis-glaucoma-hyphema).35,82,148

The difficulties reported by surgeons at that
timewho had none of the modern sterilization
techniques, operating microscope, ophthalmic viscosurgical devices (OVDs), microsutures, and quality grinding and polishing of the IOL to avoid sharp
edgeswere considered insurmountable. This report marked the end of the pioneering phase of
phakic IOL implantation and influenced more than
40 years of bad reputation, or even actual ostracism.
Die-hard prejudices are still strong against a procedure that, since its arrival, has been controversial.
For approximately 20 years, anterior chamber
IOLs gained from continued improvements in loop
flexibility and design, but only for correcting
aphakia.61,62,145 Baikoff25,28,139 and Momose reviewed the old abandoned idea for phakic eyes in
1987. Momose invented his spider lens, a two-piece
lens with a glass optic (refractive index 1.62)
surrounded by a polyamide ring that formed the
four-curved haptics, to be fixated at the chamber
angle. The overall length ranged between 12.5 and
13.5 mm. The first reports described no significant
intraoperative complications and no loss of best
spectacle-corrected visual acuity (BSCVA).208 The
mean endothelial cell loss amounted to 5.3--7% and
was stable at 3 years. However, gonio-synechiae
formation with the haptics, and frequent decentering (sunset) of the heavy glass optic made the spider
lens go down in history as a curious example of
ACP-IOL.
The Baikoff ZB lens26 (Domilens, Lyon, France),
a modified version of the highly popular Kelman
AC-IOL for aphakia,145 started the modern era of
phakic IOLs fixated in the irido-corneal angle. It was
a one-piece PMMA lens, with four fixation points
and an optic diameter of 4.5 mm. The surgeon
chose the most suitable of the three available overall
lengths (12.5, 13.0, and 13.5 mm) by adding 0.5 or
1.0 mm to the external horizontal white-to-white
distance, measured with a surgical caliper. The
manufacturers recommendations included an endothelial cell count of at least 2,500/mm2, a central
chamber depth (including the corneal thickness) of
at least 3.2 mm for powers from 27.0 to 215.0 D,
3.4 mm for stronger lenses and a minimum iridocorneal angle opening larger than 2 using the
Shaffer grading classification.234
The initial results were encouraging,65 as 80% of
the eyes fell within 1.0 D of the expected outcome,
although the power calculation was very empirical.
Up to 210.0 D, the same spectacle refraction was
used as the lens power; 11.0 D was added to values
between 210.0 and 215.0, and 12.0 D to refractions in excess of 215.0 D.
552
Unfortunately, 3 years later at least 10% of these

eyes showed worrisome signs of progressive endothelial loss, caused by the traumatic contact between
the edge of the optic and the nearby internal layers of
the cornea, that were too close together.181 In 1991
two-year outcomes on animal (monkey) eyes59,193,207
showed some degree of erosion and/or uveal
envelopment of the haptic and a decrease in
endothelial cell counts, despite good positional
stability, no significant inflammation, and no evidence of cataracts or cystoid macular edema. To
overcome this problem, the second-generation
model (called ZB5M or ZB5MF by Domilens)58
reduced the effective diameter of the optic to 4.0
mm (0.5 mm of carrier ring with no optical power;
this gave a total diameter of 5.0 mm), thus limiting
the peripheral thickness of the optic and increasing
the safety distance between the edge and the
endothelium27 with a reduced vault height (Fig. 2).
More refined criteria were introduced for power
calculation.
In 1994, a French multicenter study with 18
months of follow-up gave the same predictability as
for the ZB (75% of the eyes were within the range
of 61.0 D). Iridopathy was the most significant
complication,225 with pupil ovalization, low-grade
inflammation, peripheral synechiae, and sectorial
atrophy of the iris. Pupillary block glaucoma was
occasionally observed in eyes where iridectomy was
not done. Almost all the patients implanted with this
ACP-IOL experienced nighttime visual symptoms.
In a more recent study199 including 134 myopic
implanted eyes, the mean endothelial cell loss was
3.3% at 6 months, 4.4% at 1 year, 4.5% at 2 years,
and 4.6% at 3 years.
In 1997, the third generation of rigid Baikoff

ACP-IOLs, the NuVita MA20 (Bausch & Lomb, Salt
Lake City, UT, USA) incorporated further changes
of the optic: the PMMA material was smoothed by
a fluorine-plasma treatment to minimize tissue
friction and cell adhesion; the effective optical zone
was increased to 4.5 mm; and peripheral detail
technology was applied to the edges.27 The haptics
were re-styled to improve their conformity with the
chamber angle shape and to achieve a smoother
distribution of the compression.
However, despite good preliminary results13all
the eyes lay within the 61.0 D range, a small
proportion (5%) of pupil ovalization, no disabling
glare (an increase in mesopic vision was reported in
80% of cases and there was no loss of contrast
sensitivity at different spatial frequencies), with
2.35% endothelial cell loss at 1 yearthe NuVita
was withdrawn from the market.
Three other rigid PMMA, angle-fixated lenses
deserve mention because of their widespread use in
Europe:
1) The ZSAL-4/Plus lens (Morcher, Stuttgart,
Germany) is the fifth generation of the ZS
series. It has long, thin, flexible Z-shaped
haptics with an effective 5.3-mm plano-concave
optical zone and a transitional edge to reduce
night halos. The haptic geometry has been
designed to increase flexibility and disperse
compression forces against angle structures by
ensuring a mean distance of 1.54 mm from the
edge of the optic (Table 1) and the endothelium, which seems to cause less cell loss.137,199,245
2) The Safety Flex Phakic 6 H2 (Ophthalmic
Innovations International, Ontario, Canada) is
Fig. 2. Left: Four superimposed VHF echographic images (Artemis 2) showing the evolution of the safety distance, that
is, the clearance from mid-peripheral endothelium and edge of the myopic optic of different generations of angle-fixated
phakic IOLs. Compared to the old ZB (top left) and ZB5MF (bottom left), the Nuvita (top right) and the foldable GBR/
Vivarte (bottom right) show the modern trend for a significantly lower vault to respect the corneal endothelial cell layer.
Right: Eye with ZB5MF intraocular lens implant.
553

TABLE 1
Distances to Endothelium of Different Anterior Chamber Myopic Phakic IOLs

IOL
ZSAL-4 I-CARE****
(optic) (5.0 mm) (5.75 mm)
V
Dc
Dp
0.8*
2.05*
1.64*
0.84/1.35**
2.01/1.5**
1.85/1.1**
Artisan/
Verisyse
(5.0 mm)
Nuvita
(4.5 mm)
Phakic 6
(6.0 mm)
GBR/
Vivarte
(5.5 mm)
Kelman Duet
(6.3 mm)
Artisan/
Verisyse
(6.0 mm)
0.9/0.9**
1.95/1.95**
1.75/1.69**
0.93*
1.92*
NA
1.00/0.75**
1.85/2.1**
1.66***
0.66/0.63**
2.19/2.22**
1.60/1.78**
0.75*
2.10*
1.5*
0.9/0.89**
1.95/1.94**
1.52/1.53**
Distances to endothelium of different anterior chamber myopic phakic IOLs assuming average values of corneal
curvature (K-reading 5 43.0 D), symmetrical ACD (central depth: 3.0 mm, 3.0-mm mid-peripheral depth: 1.9 mm),
phakic lens power of 210.0 D and central lens thickness of 0.15 mm. Distance data provided by the company are
compared with averaged data obtained with VHF echography (Artemis 2). Dc 5 central distance from endothelium; V 5
vaulting, central distance from anterior crystalline lens; Dp 5 mid-peripheral (3.0 mm eccentricity) clearance from the
endothelium to the edge of the optic. NA 5 Not available.
*
Data provided by the firm / literature, not verified by VHF echography.
**
Data provided by the firm vs. data obtained by VHF echography.
***
Data not provided by the firm, empirically obtained from VHF echography.
****
Value estimated taking into consideration proper sizing of the lens.
a heparin-coated ACP-IOL whose optic diameter is particularly wide (6.0 mm, 5.5 mm in
powers greater than 220.0 D). According to
the main investigators,110 who now claim more
than 8 years of follow-up, the disadvantages
linked to the width of the incision are fully
compensated by the gain in quality of vision.
Furthermore, thanks to the considerable flexibility of the haptics, a reduced incidence of
progressive ovalization of the pupil may be
expected (Fig. 3). The company is now creating
a foldable model, which will allow a smaller
incision.
3) The ACRIOL (Soleko, Rome, Italy) comprises
a similarly wide (5.4 to 5.6 mm) optic and an
original tripod haptic designed to ensure
optimal stability to the three available overall
lengths of 12.3, 12.8 and 13.3 mm (McGrath D:

Surgeons review phakic IOLs at the 2005
ESCRS Winter Symposium. EuroTimes 10:12,
2005).
The latest generation of angle-fixated phakic
lenses (Table 2) has a foldable optic to be inserted
through a self-sealing small incision (less than 3.5
mm). Preliminary studies with these newest ACPIOLs showed promising results in terms of safety
ratio and accuracy of the refractive outcomes:
1) The Vivarte/GBR lens (previously co-marketed
by Ciba Vision, Salt Lake City, UT, USA, and
IOLTECH, La Rochelle, France, now exclusively commercialized by Zeiss-Meditec, Jena,
Germany) is a composite, two-material, singlepiece lens, with two tripod asymmetrical haptics
Fig. 3. Chronic iridopathy resulting in pupil distortion (left) may be due to three different mechanisms: 1) inherently to
the fixation system itself, the rigid haptics induce a backward pressure of the iris root; 2) (right) an ischemia from
prolonged compression of the arterial iris blood supply, resulting in iris stroma and pigment epithelial layer subatrophy;
3) inflammation leading to iris retraction. All three mechanisms could be expected with oversized lenses in particular.
554
TABLE 2A
Brand
Name
(Manufacturer)
Phakic 6 H2
(O.I.I)
Model
Optic
Geometry
Total/
Effective
Diameter
(mm)
Single-piece
Haptic
Angulation
18
Optic
Material
(n at 35 C)
PMMA
(1.492)
Planospherical
Vivarte/GBR
(ZEISSIOLTECH)
5.5 $
10.0 D)
6.0 (# 10.0)
6.0
(Hyperopic)
Composite
One-piece
0
(12
to iris
plane)
Biconcave
5.5 / ?
ZSAL-4 Plus
Single-piece
(MORCHER)
8.9 to
11--14
Biconcave
6.3 / 5.5
I-CARE
Single-piece
(CORNEAL)
Meniscus
5.75 / ?
Heparinized 24 to
220 /
222
Surface
12 to
110 /
18
Foldable
under trial
Flexizone
Forceps
27 to
(Hydrophilic Foldable 222 /
Acrylic)
221
(1.47)
PMMA
Multifocal
Haptics
(25 to 15)
Near Add
12.50
PMMA
NO
26 to
(1.492)
220 /
223
Silicone
(1.43)
PMMA
Haptics
Injectable
Glare
shield
Hydrophilic Injectable
(26% water)
Acrylic
(1.47)
26 to
220 / ?
Lowpressure
Haptic
23 to
220 /
223
13 to
110 /
19
FDA
Status
11.5 to Phase II
14 (0.5
steps)
Calculation
Chart
7.0
2.5
3.5
2.7 (!213)
12,
Not
Van der
12.5, 13 Submitted Hejide
6.0
2.9 (213!
D !218)
3.1 (218!
D !222)
2.7
12, 12.5, Not yet Van der

13, 13.5 submitted Hejide
Trials
expected
in 2004
2.0
12, 12.5, Not

Proprietary
13, 13.5 Submitted
3.0
12,
Not
Holladay
12.5, 13 Submitted Refractive
Refractive
Formula
0.20
2.8 (#213)
0.53
3.0 ($213)
2.9
Not
provided
2,500
O2
2 YAG
PIs or
Surgical
1.308
2,500
(!40 yo)
O2
Unnecessary
2,300
O2
Surgical
2,000
O2
Optional
2,500
O2
2 YAG
PIs
2,000
(O40 yo)
1.5
Kelman Duet
(TEKIA)
Planospherical
5.8 / 5.3
Two-piece
19
Special
features
Power
range /
Max
Overall
correction Length
(D)
(mm)
210 D
Thickness
(mm)
Safety
Central Guidelines
Power Incision Optic Edge Central
ECC IC Angle
Calculation size
Optic
ACD
Peripheral (cells / Width
Formula (mm) Footplate
(mm)
ACD
mm2) (Shaffer) Iridotomy
Summary of Current Angle-fixated AC Phakic IOL Models
555
Not
?
provided
Not
?
provided
0.05
0.35
! 0.1
2)
7.0 to 8.0 / ?
?
Diffractive
?
7.0 / ?
ThinPhAc
Single-piece
THINOPT-X
Diffractive
? 5 Not disclosed as confidential by the manufacturing company.

5 Not provided by the manufacturing company, measured with VHF echography (Artemis 2).
Hydrophilic Rollable
(18% water)
Acrylic (?)
Trials
expected
in 2004
2.0
Not yet ?
submitted
13, 14
230.0
to
130.0
Trials
expected
in 2004
2.0
Not yet ?
submitted
?
Silicone (?)
?
Vision
Membrane
VM
Technology
Meniscus
5.5 / ?
Single-piece
Acrylic (?)
Injectable
3.0
?
Acrysof
ALCON
Single-piece
Hydrophobic Injectable
Phase I
Ultrathin ?
(not
specified)
Not
?
Provided
?
3)
4)
5)
(one regular Z-shaped and one modified Clooped) made of PMMA-based, hydrophobic
(0.2% water) acrylic polymers, and soft terminal acrylic cushions (Fig. 4). They are grafted
onto a hydrophilic (28% water) acrylic optic,
mainly hydrossiethylmethacrylate (HEMA)
and methylmethacrylate (MMA), which is
folded and inserted with an appropriate
device and forceps.81
The I-CARE (Corneal, Pringy, France) is a
hydrophilic acrylic monobloc lens, with 5.75
mm optic size and four independent feet to
provide a wider contact surface in the angle
support (Fig. 5). The forces developed under
compression are therefore supposed to be
smaller, so as to maximally preserve iridocorneal angle and iris structures. Despite its
geometrical shape, it was designed to provide
a longer mid-peripheral distance from the
endothelium to the optics edge (Sourdille
et al. I-CARE, a new phakic IOL. Presented at
the VII ESCRS winter meeting, Rome, January
2003), the lens turned out to be excessively
vaulted once implanted intraocularly and observed with VHF echography (Table 1). Further
refinements of the design are expected soon.
The Kelman Duet Implant (Tekia, Irvine, CA,
USA) is a two-part ACP-IOL, implantable
through a 2.0-mm incision. The tightly compressed silicone optic is inserted independently, after the tripod PMMA haptics. Two
specially fitted tabs enable the optic to be
attached to the haptics and offer the chance of
an independent exchange of the haptic or the
optic.8 A glare-preventing shield has been
added to the periphery of the 6.3-mm (effective diameter: 5.5 mm) optic. A potential
concern, common to the GBR/Vivarte, is the
tendency to move around the angle when
a patient blinks or rubs his eye,142 as it was
found with previous tripod lenses.
The Acrysof ACP-IOL (Alcon, Forth Worth,
TX, USA) is a single-piece foldable lens in
acrylic material with 5.5-mm meniscus optic
and peculiar T-shaped haptic design (Colin J:
Surgical technique for inserting the AcrySof
Phakic ACL. Presented at the ASCRS meeting,
San Francisco, April 2003).
The ThinPhAc (ThinOpt-X, Medford Lakes,
NJ, USA) is an ultra-thin (100 to 150 mm) lens
made of hydrophilic acrylic material. The
large optic (7 to 8 mm) has been designed
to enhance quality of vision by controlling
spherical aberrationone surface is lathe-cut
to retain a traditional continuous curvature,
and the second surface presents a series of
556
TABLE 2B
Summary of Current Iris-supported AC Phakic IOL models
Artisan 204 /
Single-piece
Verisyse
OPHTECH/
AMO
0
Optic
Material
(n at 35 C)
PMMA
(1.492)
Special
features
Toric
0
PMMA
(1.492)
6.0 / ?
Single-piece
Meniscus
6.0 / ?
23 to
223.5 /
224
0
Polysiloxane (?)
PMMA
haptics
35
PMMA
(1.492)
Flexible
23 to
223.5 / ?
FDA
Status
Power
Calculation
(Formula)
Safety
Guidelines
Central
ACD
(mm)
Peripheral
ACD
ECC
(cells /
mm2)
IC
Angle
Width
(Shaffer)
Iridotomy
8.5
3-year clinical
outcomes file
submitted for
PMA Pending
Approval
Expected
2004
Toric: clinical
study start
2003 (1-year
study
required)
Van der
Hejide
6.5
2.8
2,500
Surgical
8.5
3-year clinical
outcomes file
submitted for
PMA Pending
Approval
Expected
2004
Toric: clinical
study start
2003 (1-year
study
required)
Van der
Hejide
5.5
2.8
2,500
Surgical
Clinical study
start 2003
Van der
Hejide
3.5
2.8
2,500
Surgical
Not
Submitted
Russian
Vertex
Chart
7.0
2.8
2,500
Surgical
7.5
8.5
13 to
112 / ?
Anterior- 23 to
Posterior 225 /
Fixation 232
12 to
130 /
125
13
Nikai
SOLEKO
Toric
Pediatric 11 to
112 /
110
Meniscus
5.0 / ?
Artiflex/
Two-piece
Veriflex
(OPHTECH/
AMO)
Meniscus
23 to
215.5 /
215
11 to
112 /
110
Meniscus
6.0 / ?
Artisan 206 /
Single-piece
Verisyse
OPHTECH/
AMO
Power
range /
Overall
Max
correction Length
(D)
(mm)
Brand Name
Manufacturer
Model
Optic
Geometry
Total/
Effective
Haptic
Diameter (mm) Angulation
210 D
Thickness
(mm)
Central
Optic
Incision Peripheral
size
Optic
(mm) Footplate
TABLE 2C
Summary of Current Posterior Chamber Phakic IOL Models
Model Optic
Geometry
Total/
Brand
Effective
Special
Name
Diameter
Haptic
Material
Manufacturer
(mm)
Angulation (n at 35 C) features
ICL STAAR
Single-piece
Collamer
(37.5%
water)
(1.453)
Planospherical
PRL IOL
TECH
Sticklens
IOLTECH
5.5 / 5.5 (H
& M !212)
5.25 / 5.25
(212 !M
!214)
5.0 / 5.0
(214 ! M
!216.50)
4.65 /4.65 ($
217.0)
Single-piece
Planospherical
5.0 (M
!216.0 D)
4.5 (H & M
O216.0D)
Single-piece
Power
range /
Max
correction
(D)
Overall
Length
(mm)
FDA Status
23 to 221 / 11.5, 12, 12.5, 3-year clinical

218
13 (M)
outcomes file
submitted for
PMA
Pending
Approval (M)
Expected
2004
Custom 13 to 117 / 11, 11.5, 12, Toric: clinical
113
12.5 (H)
study start
2002 (1-year
study
required)
Toric
210 D Lens
Thickness
(mm)
Central
Min
Optic
Power
Incision Peripheral
Calculation
size
Optic
(Formula)
(mm)
Footplate
OlsenFeingold
Formula
2.5
Vaulting
(mm) of
ideally
sized
IOLs
0.10 / 0.23** 0.30 to 0.50

(M)
Proprietary
Nomogram
0.55
Average
Safety
Min
IC Angle
Guidelines
ECC
Min ACD (cells / Reduction
(%)
(mm)
mm2)
2.8
2,000 to
2,500
(depends
on age)
28
2.5
2,000
20
2.8
2,200
! 10
0.20 to 0.30
(H)
0.07
Hydrophilic
silicone
(1.46)
NO
23 to 220 / 10.8, 11.3

227
(M)
Phase III
Holladay
Refractive
1.8
13 to 115 / 10.6 (H)

111.50
0.22
0.35 (M)
0.52
0.25 (H)
0.08
Hydrophilic
(28%
water)
acrylic (?)
Meniscus
6.5 / ?
M 5 Myopic, H 5 Hyperopic, T 5 Toric.
NO
27 to 225 /
?
14 to 17 / ?
11.5
Not
Submitted
Van der
Hejide
3.0
Almost zero
558
achieved through diffractive technology (Haddrill M: Status report: Phakic IOLs. EyeWorld,
April 2003, pp 62--3).
The Vivarte/GBR, the I-CARE, and the Kelman
Duet implants have already obtained the CE mark
and are commercially available in Europe. The
Acrysof, the ThinPhAc, and the Vision Membrane
lenses are in the very initial phase of small,
controlled clinical trials in a few study centers in
Europe and Russia.
Fig. 4. The GBR/Vivarte foldable angle-fixated phakic

IOL in situ.
steps/rings 50 mm in height, each with a slightly

different curvature, to remain within microns
of the opposite surface, along the principle of
Fresnel optics. The lens, provided without
limits of correction (630.0 D), is rolled in an
injector device, and then gently inserted
through a micro incision (1.5 mm) to get
fixated in the irido-corneal angle. The lens
extremely light weight should limit the forces
that may potentially disrupt internal tissues,
with the pliable haptics that compensate for
size error by simply rolling or unrolling at the
fixation site (Alio J: ThinPhAc phakic IOL.
Presented at the Alicante Refractiva Congress,
Alicante, March 2004).
6) The Vision Membrane Lens (Vision Membrane
Technology, Carlsbad, CA, USA) is a minimalincision, silicone ACP-IOL with a large optic
diameter (7.0 mm) and a remarkable thinness
Fig. 5. The I-CARE foldable angle-fixated phakic IOL

in situ.
Iris-Supported Lenses
Using the iris structure to support the IOL was
initially suggested in aphakic globes with a view to
avoiding the main problems encountered with angle
fixation. Starting in 1953, the first-generation
models with anterior and posterior loops (like
Epsteins Maltese cross, Binkhorsts iris-clip,42,43
the Sputnik by Fyodorov,101 and Worsts Medallion
lens255) were supported by the highly mobile iris
sphincter, close to the pupillary border. These
invariably created problems with progressive erosion
of the iris stroma and breakage of the blood/
aqueous barrier, eventually leading to IOL dislocation, uveitis and glaucoma.
Those complications inspired Worst to design the
iris-claw, also known as the lobster-claw lens, a coplanar one-piece PMMA IOL. The haptics had fine
fissures to capture, through enclavation with a specific needle or forceps, a fold of mid-peripheral iris
stroma, a virtually immobile portion halfway between the pupillary edge and the iris root. As this is
less vascularized and reactive, it was expected to
safely bear the pressure of the claws without
inhibiting the iris function.
Many surgeons used the iris-claw lens after intracapsular cataract extraction or as secondary implantation in aphakia. In 1980, Worst91 implanted an
opaque optic iris claw lens in a phakic eye for the
first time, to solve untreatable diplopia. In 1986,
Fechner implanted the first sighted myopic eye.89 In
1993, he reported the results of a 5-year retrospective study on 127 eyes implanted with an iris-claw
model known as the Fechner-Worst lens, which has
now been discontinued.85,86,88 Predictability was
fairly good (68% of the eyes fell within the 61.0 D
range), no intraoperative complications were observed, but there was progressive endothelial cell
loss (around 7%). Menezo reported a similar figure
(7.5% cell loss) at 1 year.178 In 1993, a multicenter
international trial published by the manufacturer
on 99 eyes reported excellent results in terms of
BSCVA lines gained. Predictability was as good as
with the Baikoff lenses (81% of the eyes between
559
61.0 D). At 1 year, the percentage of endothelial

cell loss was the same (7%).
While most angle-fixated ACP-IOLs have involved
significant developments, the currently available irisclaw model, the Artisan lens (Ophtec, Groeningen,
The Netherlands), also known under the brand
name of Verisyse (after the exclusive distribution
agreement with Advanced Medical Optics, Santa
Ana, CA, USA), is basically the original IOL with
a long track record as its most distinctive advantageous feature.50
It is a one-piece PMMA IOL (Fig. 6), available in
two meniscus-shaped optic diameters of 5.0 and 6.0
mm (the wider optic comes up to 215.50
D);157,158,169,170 in the hyperopic lenses the optic
diameter is always 5.0 mm.227 The fixed overall
diameter of the lens (generally the one size fits all
length is 8.5 mm, with a 7.5-mm diameter available
for pediatric implantations or to adapt to small eyes)
is perceived as a great advantage to the surgeon who
does not wish to deal with sizing measurements and
expensive instrumentation. The average vaulting,
that is, the central distance from the crystalline lens,
is 0.9 mm. To select the correct power, the firm
suggests the nomogram, perfected by van der
Heijde,120 which takes into consideration spectacle
refraction, keratometric value and the anterior
chamber depth (ACD).
Throughout the years, the claw principle has
enjoyed continuous success, even in hyperopic eyes,
with the longest and most reassuring follow-up in
the field of phakic IOL. According to updated
figures issued by the company more than 40,000
Worst lenses have been implanted for aphakia, and
another 25,000 in phakic eyes.88 The findings
regarding endothelial behavior over the years are
encouraging. Endothelial cell loss seems similar
to the loss occurring after routine cataract surgery
(3--5%) and over time the mean cell change does

not seem significantly greater than the natural loss
(0.57% annually).4,9,50,119,142,171 The prospective
clinical trial evaluating the endothelial cell count
change on the first 765 eyes enrolled at the FDA
sites showed no statistically significant postoperative
cell loss at 2 years.204 In the same population,
complications that occurred at 2 years, such as
pigment precipitates (8.3%), lens anterior capsule
vacuoles (2.8%), and irregular pupil (2.8%) were
considered clinically insignificant. Only visual symptoms like glare and halos reached a significant rate
with the 5-mm optic (11.7% vs. 3.2% with the 6-mm
optic).142 Nevertheless, for many international
authorities, the potential progressive endothelial
cell loss remains a matter of concern. In the small
incision era, the foldable iris claw phakic IOL, called
the Artiflex/Veriflex, has recently obtained the CE
mark and become commercially available in Europe.
It has rigid PMMA haptics attached to a soft silicone
(polysiloxane) 6.0-mm optic.51 The unfolded lens
flexes through the 3.2 mm incision and returns to its
original shape inside the anterior chamber when
implanted with an appropriate device.
Anterior-Posterior Phakic IOLs
In 1986, when Baikoff and Fechner started investigating the anterior chamber fixation, Fyodorov
and Zuev101 began implanting IOLs with anteriorposterior placement. The first model, called a collar button or mushroom," was a one-piece silicone
lens, with a 3.2-mm optic concave on the frontal
surface that projected anteriorly through the pupil
and was fixated behind the iris plane by two haptics,
with a total length of 8.0 mm (Fig. 7). The small
diameter of the optic created nighttime disturbances
and photophobia under bright lighting, because
Fig. 6. The Artisan/Verisyse iris-fixated phakic IOL in situ (left) with a detail of the mid-peripheral iris stroma enclavated
by the haptic claw (right).
560
Fig. 7. First-generation collar button anterior-posterior phakic IOL, outside the eye (left) and in situ (right).
(Photographs courtesy of Dimitri Dementiev.)
the pupil was unable to constrict beyond 4.0 mm.

Pupillary block glaucoma and iridocyclitis were also
frequent. At a later stage, corneal decompensation,
late-onset uveitis, and cataract were reported.100,102
Therefore, Fyodorov decided to interrupt the study
of these implants, and started to explore whether the
posterior chamber (PC) might be a more welcoming
environment for a phakic IOL.
The only anterior-posterior phakic IOL currently
available is the Nikai lens (Soleko, Rome, Italy),
a one-piece PMMA lens with a 6.0-mm optic and
a total length of 13.0 mm. A single spiral-shaped Cloop that is unusually long (260 circumference),
lies 0.95 mm more posteriorly to the optic plane.
The loop is inserted in the ciliary sulcus through the
iridectomy, while the optic plane stays in the
anterior chamber, in the pre-pupillary area.165 At
the time of this writing, only anecdotal reports but
no reliable data have been presented.
POSTERIOR CHAMBER PHAKIC LENSES (PCP-IOLS)
In 1990, after the collar button lens, the project at

the Moscow Eye Institute stumbled along and
second-generation lenses were introduced. The
optic was enlarged, and the haptics were made flat
and rectangular, similar to the modern plate haptic
IOL for aphakia.100,165 For the first time the implant
was placed entirely inside the posterior chamber.
In order to calculate the power of the implant,
surgeons employed the same rule of thumb already
used for anterior chamber models, according to
which for up to 10.0 D of myopia the dioptric power of
the IOL corresponded to the refraction on trial
frames; 11.0 D was added to values between 210.0
and 215.0, 12.0 D to refractions in excess of 215.0 D.
In the short term, the most frequent complications

were decentration (the overall length of 10.0--11.0
mm was too short for stable positioning) and
endothelial cell loss, as the ophthalmic viscosurgical
device (OVD) was used very sparingly.100,102 In the
long term, these lenses have been subject to considerable criticism, due to the appearance of corneal
decompensation, secondary glaucomas, and subcapsular cataract.46,144,253 Thus they are no longer
available commercially in Europe, but can still be
obtained (Optimap, Moscow, Russia) with greater
overall length (11.5--12.5 mm) and optical zones
(4.5--5.5 mm, depending on the dioptric power).
On the heels of the first experience outside
Russia,84 Fechner moved from the pre-pupillary site
of the iris claw to the retro-pupillary space,87 with an
elastomer model produced by Adatomed (Munich,
Germany). With a wide range of powers (up to
225.00 D), the characteristic features were the long
overall length (up to 12.5 mm) and a larger optic
diameter (5.5 mm). This model fell slowly into
disuse because of anterior lens fibrotic opacities in
the contact zones with the thick edges of the IOL
(Fig. 8).165,174,179,180 There is no convincing evidence that the initial suspect (hydrophobic properties and the low refractive index of the elastomer,
causing pronounced edge thickness) was the issue.
Some authors think contour was more likely to be
responsible for cataractogenesis.
The latest version of these lenses is the PRL
(Phakic Refractive Lens),75,76 now marketed by
Zeiss-Meditec (Jena, Germany), formerly by Ciba
Vision (Salt Lake City, UT, USA) and IOLTECH (La
Rochelle, France), after the commercial rights were
purchased in 2000 from developer Medennium
International Vision (Cincinnati, OH, USA)
(Fig. 9). The PRL is made of a new-generation,
561
Fig. 8. Slit-lamp (top left) and retroillumination view (top right) of an iatrogenic anterior fibrotic subcapsular cataract
induced by an elastomer posterior chamber phakic IOL (Adatomed) 28 months after surgery. Twelve months
postoperatively, the Scheimpflug camera had shown good crystalline lens transparency (bottom).
ultra-thin hydrophobic silicone with a refractive

index of 1.46. The diameter of the optic is 4.5--5.5
mm, depending on the lens power. The posterior
base curve is concave to mimic the anterior
curvature of the crystalline lens (10.0-mm radius of
curvature). The front curve varies with correction;
in myopic lenses it starts with a large-radius convex

surface approaching an almost flat surface, then
shifting to a concave surface for the higher powers.
The hyperopic lens has a convex front surface.
Central thickness is less than 0.5 mm and is constant
for myopic lenses, but varies with hyperopic lenses.
Fig. 9. The PRL posterior chamber phakic IOL in situ (left). Retroillumination Scheimpflug camera (EAS 1000, Nidek,
Japan) image of a decentered PRL (right).
562
The edge thickness is always less than 0.2 mm. It is

constant in hyperopic lenses and varies in the
myopic ones. Although a 10.8-mm version is available for horizontal corneal diameters (white-towhite distance) less than 11.0 mma very rare
findingone single size is more commonly used,
the 11.3-mm for myopic eyes, the 10.6-mm overall
length for all hyperopic eyes. The company claims
the lens has no anatomical fixation sites and floats
on a layer of aqueous humor inside the posterior
chamber, exerting no pressure on the ciliary
structures and without coming into contact with
the anterior capsule of the crystalline lens.46,133
Possible complications are decentration (Fig. 9),
cataract formation, pigmentary glaucoma,246 and
dislocation into the vitreous (Lovisolo CF: Posterior
chamber phakic IOLs. ISRS/AAO 2003 Refractive
Surgery comes of age. American Academy of
Ophthalmology, pp 33--41). Particular features are
the lowest safety limits suggested by the company (a
minimum endothelial cell count of 2,000 cells/mm2
and a central anterior chamber depth not less than
2.5 mm) and the highest effective myopic correction
achievable on the market (228.0 D at the spectacle
plane).
In an attempt to make the lens material lighter,
more hydrophilic, and permeable to gas and
nutrients, a small proportion (0.2%) of porcine
collagen was added to the silicone in the early 1990s.
Collagen addition increased biocompatibility with
the nearby structures by attracting the deposition on
the lens surface of a monolayer of fibronectin, which
inhibits aqueous protein binding, thus making the
lens invisible to the immunitary system.232
Staar (Monrovia, CA, USA) patented92 this
material made of 60% poly-HEMA, water (36%),
and benzophenone (3.8%) and called it the
Collamer (collagen-copolymer). The lens was called
the ICL (implantable contact lens), as initially it was
thought that it would come into contact with the
anterior surface of the crystalline lens.215
In fall 1993, Pesando, Assetto, Benedetti, Zaldivar
and Skorpik implanted the first ICL prototypes
(IC2020).22 The optic was small (3.5--4.5 mm) and,
in view of the sketchy knowledge of the physiological
optics of in vivo implants, the concern was that the
considerable thickness of larger optics would have
caused problems. Nighttime visual symptoms were
the immediate postoperative complication, and
about one patient out of three had early angleclosure glaucoma. Since then, two well-patent
peripheral Nd:YAG iridotomies performed two
weeks before surgery or an intraoperative surgical
iridectomy, have become mandatory.
In 1994, a new version became available (IC2020-M,
overall length 11.5 mm and optic 4.5 mm) with
better results.165 Decentration was still an issue,

because of the small overall length of the lens, but
the main problem was undercorrection. For some still
unknown reason,165 the in vivo effective power of the
ICL, calculated by the Feingold-Olsen formula,
appeared to be underestimated by 25% of the in vitro
predicted value. This was the start of a long period of
work to improve the theoretical formula used for the
predictability of the refractive outcome. It ended in
1998 thanks to the regression analysis that finally
allowed users to achieve results in the range of
61.00 D in the vast majority of patients.165,262,264
At least four clone models followed the IC2020
prototypes. Until the second half of 1996, the lens
had no identifying marks. As a result, when it was
injected, it was hard to recognize if the lens had
folded over on itself and entered the chamber
upside-down. To avoid this risk of inversion, many
surgeons preferred to implant the lens using forceps.
The injection technique became popular when the
manufacturer produced a model (ICM115,120,125
or 130; V2 [Version Two]) with orientation markings
on the haptics, allowing control during the unfolding maneuvers and ensuring the advantages of
a small incision.
For the older versions (V2 and V3 in particular),
the complications reported were small percentages
of pupillary block glaucoma and pigment dispersion. However, late anterior subcapsular opacities of
the crystalline lens occurred in 5--30% of cases after
1 to 3 years of follow-up (9.2% of the FDA cohort V3
series224).
The current model (the Visian ICL V4 [Version
Four]) is a rectangular one-piece lens, 7.5--8.0 mm
wide, available in four overall lengths (11.5, 12.0,
12.5 and 13.0 mm for the myopic lenses, 11.0, 11.5,
12.0, and 12.5 mm for the hyperopic ones). The
optic diameter ranges from 4.65 to 5.5 mm in the
myopic lenses, depending on the dioptric power,
and is always 5.5 mm for hyperopic ICLs.70,165,223 Its
basic design change is in the vaulting. The V4 has
an additional 0.13 to 0.21 mm of anterior vault, due
to the steeper radius of curvature of the base curve
and depending on dioptric power.224 Myopic lenses
(ICM) are plano-concave with the plano surface
facing anteriorly, whereas the hyperopic ones (ICH)
are meniscus-shaped (concave-convex), with convex
on the anterior surface (Fig. 10).223 According to
updated figures issued by the manufacturer, about
30,000 ICLs have been implanted throughout the
world and late cataract incidence, after properly
sized V4 models, is less than 0.6%.224 It is important
to emphasize that this percentage might differ from
other reports, including the FDA experience, due
to differences in the criteria of how cataract is
defined.
563
Fig. 10. A V4 myopic Visian ICL in situ (left). If compared with the previous generation, the last version (V4) has
a steeper base curve to provide a higher vault (right). (Reprinted with permission of Staar Surgical.)
The Sticklens (IOLTECH, La Rochelle, France) is

a newest posterior chamber phakic IOL made of
a single piece of hydrophilic (28% water) soft acrylic
material, which has already shown excellent biocompatibility when used for aphakic implants. Its
main feature is that it sticks firmly to the anterior
surface of the crystalline lens, hence the name. Only
the anterior radius of curvature varies, while the
overall length (11.5 mm), the posterior shape, and
curvature are fixed to match the anterior surface of
the crystalline lens. The thickness of both optic (6.5
mm wide) and haptics is minimal, and a smooth
slippery surface optimizes the contact with the
anterior crystalline and posterior iris surfaces. Four
closed-loop haptics with large apertures seem to
ensure a sort of piston-suction effect to maintain the
supply of nutrients to the crystalline lens from
aqueous flow, so it is claimed that, contrary to what
was previously thought, vaulting is not necessary to
prevent cataract formation (Lorenzo JA: Sticklens
Phakic Acrylic IOL for High Myopia: 53-Month
Results. Presented at the ASCRS meeting, San
Francisco, April 2003).
The Sticklens is in the preliminary phase of
clinical trials in a few study centers in France and
Argentina.
Preliminary Work-Up
CHOICE OF LENS
Calculating the Power

Phakic IOL surgery can no longer afford postoperative refractive surprises, as in all cases the
current standard-of-care precision must be 61.0 D
from attempted refraction. Therefore, the theoretical approach to calculating lens power is as
important as the proper surgical technique, and
the old empirical golden rules need to be aban-
doned. Fortunately, the latest generation formulas

are very accurate, provided that the measurements
they require are precise. Inaccuracies still arise,
mainly due to human errors in measuring corneal
curvature (especially in contact lens wearers or in
eyes that have already undergone kerato-refractive
surgery) and irido-corneal angle or ciliary sulcus
dimensions.128,206
As in secondary IOL implantation in aphakic eyes,
or piggy-back implantation, the power of a phakic
IOL positioned at a given distance behind the main
corneal surface is equivalent to the power of the lens
measured at a given distance (V) from the corneal
vertex.126,211 The most commonly used formula is
the following:
PIOL 5
1336
2
2ELP
1336
1000
1000 2V 1K
Rpreop
1336
2ELP
1336
1000
1000 2V 1K
Rdes
It takes into account six classical parameters:

-----
corneal power (K), in diopters

effective power of the IOL (PIOL), in diopters
preoperative refraction (RPREOP), in diopters
desired postoperative refraction (Rdes), in
diopters
-- distance of the refraction plane from the
corneal vertex (V), in mm
-- effective or expected position of the IOL
(ELP), in mm, that is, the distance between
the secondary principal plane of the cornea
and the principal plane of the IOL
The classic approximations of thin lenses are

assumed,42,96 or rather the corneal and IOL
thicknesses are ignored, so the vertices of the
anterior and posterior surfaces coincide. It is not
necessary to determine the biometric dimensions of
the globe (axial length, crystalline lens thickness,
564
and vitreous chamber), as they remain completely

unchanged.
To select the power of anterior chamber phakic
IOLs, many manufacturers recommend the formulas devised by Van der Heijde:90,120
PIOL 5
1336
1336
21336
2ELP
K
1336
2ELP
K1Refc
where Refc 5 refraction at the corneal vertex, in

diopters.
The effective lens position (ELP), in meters, is
calculated as the difference between the anterior
chamber depth including the corneal thickness
(ACD) and the distance between the IOL and the
crystalline lens (around 0.8 mm in the Artisan/
Verisyse lens, 0.6 mm in the Baikoff ZB5MF, 1.0 mm
in the ZSAL-4)165 (Vaz F, et al: Anatomical Evaluation of Three Types of Phakic IOL. Presented at the
XVI ESCRS Meeting, Nice, September 1998). For
example, if we have a myopic eye with a spectacle
correction (vertex distance 12 mm) of 218.0 D, K
44.0 D and ACD 3.8 mm, the power of the three
ACP-IOLs can be calculated as follows:
ELPArtisan=Verisyse50:0030:003820:0008;
ELPZB5MF50:0032 0:003820:0006;
ELPZSAL-450:0028 0:003820:001
For an ICL implant, the majority of users employ
the formula perfected by Feingold and Olsen,99,188,189 which starts the calculation from the
12-mm spectacle plane or the vertex refraction.
Again, a crucial factor is the ELP, or rather the
expected position occupied by the ICL. The socalled equivalent contact lens power (ECL) at the
corneal level is calculated as follows:
ECL51; 000$S:E:=1; 0002V$Rres
Different values of a surgical constant (c) are
introduced to achieve the ECL in myopic
(CM58.0) and hyperopic (CH512.0) corrections.
The power of the ICL (PICL), in D, is calculated as
follows:
PICL 5
1336
1336
2T2ACD20:1
K1ECL
1336
1336
K2T2ACD20:1
where
K 5 mean corneal power [(K1 1 K2) / 2)], in D
T 5 corneal thickness, in mm
ACD 5 depth of the anterior chamber, in mm
BCL 5 power of the contact lens, in D
RRes 5 residual refraction, in D
An adjustment factor of 5% is added to the

calculated dioptric value.
To calculate the PRL power, many surgeons still rely
on the Russian Vertex Chart, where the spherical
equivalent of the most accurate refraction on the
spectacle plane (V 5 12 mm) is used to interpolate
the power of the lens. Rough as it may seem, this
method appears to provide acceptable accuracy.75
Sizing the Overall Length
Despite the lack of scientific proof behind it, the
vast majority of surgeons worldwide still behave like
the early pioneers, selecting the overall diameter of
the phakic IOL according to the golden rule of
thumb by adding 0.5--1.0 mm to the horizontal
corneal diameter (white-to-white distance, W-to-W)
obtained externally, with the exceptions being the
Artisan/Verisyse and the PRL, marketed as one size
fits all lenses. Although obviously empirical, the Wto-W based sizing protocol is considered sufficiently
safe and effective by many authorities. In the ICL
FDA study that adopted the protocol, the replacement rate due to symptomatic over-undersizing
issues224 was 1.5% (8 out of 526 implanted eyes).
When done preoperatively at the slit-lamp by
comparison with a ruler or gauge, or using the
surgical caliper, the reproducibility margin (60.79
mm) of this direct-view type of W-to-W measurement
is poor because the landmarksthe points where
white begins and gray starts at the limbusare open
to each surgeons personal interpretation. More
standardized strategies, based on the analysis of digital
photographs from videokeratography or laser partial
coherence interferometry images (IOLMaster) have
slightly improved the precision (in our hands)
achieving reproducibility tolerances of 0.4-0.6 mm
for the different systems on the market. Moreover,
although the Orbscan seems to provide smaller
measurements, the white-to-white values provided by
the IOLMaster look larger when compared with the
measurements obtained with the surgical caliper.
The findings from in vivo ultrasound studies21 and
anatomic observations on cadaver eyes252 were
recently confirmed by a MRI study (Fea AM et al:
MRI measurements of white-to-white and sulcus-tosulcus distances for ICL implantation. Presented at
the AAO Meeting, Orlando, FL, November 2002).
Contrary to previous anecdotal reports, the ciliary
sulcus diameter (sulcus-to-sulcus distance) is generally smaller than the anterior chamber diameter
(angle-to-angle).206 In Caucasians, a mean horizontal W-to-W distance of 11.7 mm (vertical W-to-W
11.0 mm) corresponds to a mean horizontal A-to-A
distance of 11.9 mm and a mean horizontal sulcus-tosulcus (S-to-S) distance of 11.2 mm. Whether the
anatomical shape of the ciliary sulcus is oval (some

eyes show vertical dimensions longer than the
horizontal ones, some others do the opposite) or
round is a controversial matter of debate. The
standard deviation of all measurements is in the
range of 0.9 mm. However, regardless of the accuracy
of the measurement of W-to-W, there is no proportional anatomical correspondence between external measurements and internal dimensions of the
anterior segment compartment (Fig. 11).15,21,165,252
As a consequence, W-to-W distance alone cannot
predict either angle or sulcus size and seems totally
inadequate for sizing phakic IOLs.165,206
Instead, the exact internal linear anterior chamber
depth, angle-to-angle (A-to-A) and S-to-S distances,
the distance between the iris and the ciliary processes, and angular dimensionsthe width of the
irido-corneal angle, the iris-crystalline angle, the
irido-scleral angle, and the sclero-ciliary anglemeasured point-by-point at different levels, should
be used. Images of these hidden anatomical sites can
be obtained with high-resolution ultrasound devices
that use very high frequency (VHF) waves in the 50MHz range. The first-generation VHF ultrasound
systems (the UBM, Humphrey Zeiss/Paradigm, Salt
Lake City, UT, USA, and the I3ABD, Innovative
Imaging, Sacramento, CA, USA), operate at frequencies of 50 MHz and 20 MHz, respectively, and provide
corresponding axial resolutions of approximately 30
microns and 75 microns. However, because lateral
scan width is limited to 5 mm (UBM) and 8 mm (I3),
these instruments cannot measure the angle and
sulcus dimensions in one scan sweep. Their use is
limited to the combination of multiple images
pasted together, which is fraught with inaccuracy
because of the necessary eye movements and the
difficulty of registration of separate image frames.
Both systems also use sector scan geometry. Wideangle sector scans of the anterior segment must
necessarily have an increasingly oblique angle of
Fig. 11. Schematic image of external, white-to-white (Wto-W) and internal measurements, angle-to-angle (A-to-A)
and sulcus-to-sulcus (S-to-S) distances, relevant for sizing
phakic IOLs.
565
incidence upon the surface of the eye as the

transducer direction becomes more peripheral to
the ocular axis. The effect of this is two-fold: first,
oblique incidence results in deflection rather than
reflection of the ultrasound beam, with consequent
loss of signal. Second, because the speed of sound in
the cornea and sclera are significantly different from
normal saline or aqueous fluid, these structures act
as acoustic lenses, refracting the ultrasound beam,
distorting intraocular anatomy and causing measurement inaccuracies.
The Artemis 2 system developed by Ultralink (St.
Petersburg, FL, USA) uses a 50 MHz transducer that
is swept in an arc matching the curvature of the
anterior of the eye. In addition, the Artemis uses
a more sophisticated system for acquisition of data,
storing the actual echo data (from which images are
formed) instead of the image itself. An optical
system for eye fixation and alignment allows direct
visualization to confirm the exact position where
measurements are taken. Then a computer-controlled scan along multiple clock-hours permits 3D
biometric mapping of the eye.210
Zeiss provides surgeons with all three sizes with
their Vivarte/GBR angle-fixated lenses and recommends intraoperative measurements of the angle-toangle distance with an internal ruler inserted
through the main incision. A similar intraoperative
method has been proposed using a two-piece device
(BioShape AG, Berlin, Germany), a centration ring
with an outer diameter of 11.0 mm placed on the
eye and an angled spatula with a scale on the handle
simulating the shape of the haptics (Tetz M:
Instrument provides exact measurements for anterior chamber intraocular implants. Ocular Surgery
News Jan 2000). The eye is filled with a cohesive
OVD and the ruler or spatula is pushed forward
until it comes into contact with the angle; the
measurement is taken by making the scale of the
ruler and the handle of the spatula correspond with
the center of the pupil or the center of the cornea,
which is previously marked with a Sinskey hook.
Because there are several sources of potential bias,
like the movement of the center of the pupil
induced by pharmacological miosis, or the surgeon
pushing more or less strongly towards the angle, the
centration on the top of the cornea has to be based
on the white-to-white reference, so the tolerance of
this method (in our hands: 60.65 mm) is still
unacceptable for our purposes.
For ACP-IOLs, the externally invisible iridocorneal angle diameter can be visualized with an
indirect no-contact procedure, using the LED SIZER
(IOLTECH, La Rochelle, France) or by infrared
light optical coherence tomography (OCT-Visante,
Zeiss-Meditec, Jena, Germany) (Fig. 12). The LED
566
Fig. 12.
LEDSIZER (left) and OCT-Visante (right) images of the anterior segment of the authors right eye.
SIZER provides automatic measurements of the

angle-to-angle distance in different meridians
through an analysis of the contrast changes of the
images produced by a visible-light source (an
electroluminescent diode) passing through the
sclera covering the trabecular meshwork. The OCT
permits high-resolution cross-sectional anterior segment imaging with excellent reproducibility of
measurements by using the interference profile of
the reflections from the cornea, the iris, and the
crystalline lens.38,254 These methods are less interesting for sizing PCP-IOLs because the retroirideal space cannot be perfectly visualized by
optical devices and the statistical correlation between angle and sulcus diameters is as poor as
between external white-to-white and internal dimensions. However, the choice of the proper overall
length of the implant is equally crucial for PCPIOLs, particularly the ICL.165 Excessive vaulting
induced by too long lenses may cause the iris
diaphragm to bulge forward, with narrowing of the
irido-corneal angle, chafing of the posterior iris
surface, pigment dispersion and subsequent risk of

angle closure and pigmentary glaucoma (Fig. 13),
ocular pain or tenderness due to nerve irritation by
excessive pressure in the ciliary sulcus.
On the other hand, lack of vaulting because of
short ICLs has caused iatrogenic anterior subcapsular cataract.165 A full circle of mechanical contact
all 360 between the edges of the myopic ICL and
the crystalline lens trapped the aqueous circulation
in the prelenticular space and prevented nutritional
turnover on the lens surface, with negative repercussions on the vitality of the lens subcapsular
epithelial cells.
The consequences of unpredictable vaulting include refractive inaccuracy due to inappropriate
positioning of the nodal points of the lens.106 The
ideal vault height for an ICL seems to be around
350 (300--400) mm in myopic (Fig. 13) and 250
(200--300) mm in hyperopic implants, to provide safe
separation from the anterior surface of the crystalline lens and minimize untoward effects on aqueous
hydrodynamics.165 Hyperopic ICLs can have a lower
Fig. 13. VHF echography (Artemis 2) image of a perfectly sized V4 myopic ICL with a vaulting of 305 microns (left).
Scheimpflug camera (EAS 1000) image of an excessively vaulted V2 myopic ICL (right).
567
vault than their myopic counterparts because the

peripheral geometry of positive lenses leaves more
space in the periphery to the circulation of nutrients
and hyperopic eyes tend to have shallower chambers
with narrower angles.209 It is the opinion of many
ICL-surgeons, the authors included, that a minimum
mid-peripheral clearance of 150 mm is required.
When we observe lower vaulting or mechanical
contact, ICL explantation and/or exchange with
a larger overall size should be considered for the
high risk of iatrogenic cataract. The surgical choice
is not easy, as a second open-eye procedure carries
its own disadvantes.
A modified trigonometric formula can be employed to size the ICL, and thus to predict vault
height precisely. The variables entered into the
formula include the sulcus-to-sulcus distance and
the radius of curvature of the anterior surface of the
crystalline lens, obtained with the Scheimpflug
camera, standard (the EAS 1000, Nidek, Tokyo,
Japan) or rotating (the Pentacam, Oculus, Wetzlar,
Germany), as well as with VHF echographers. The
constants in the formula include the elasticity of the
collamer and the base-curve of the ICL.
Since 2002, we have been using a software devised
by Lovisolo and Calossi to simulate the expected
clearances between corneal endothelium, iris and
crystalline lens for all our phakic lens implantations.
The software (Fig. 14) takes into consideration:
1) The three-dimensional map of the biometric
data of the patients anterior segment as
obtained from VHF ultrasonography (Artemis
2) and optical tomography (Orbscan II, Bausch
& Lomb).
2) The specific features of the chosen lens implant
(overall length, vault, central and peripheral
optic thickness, flexibility).
Fig. 14. The Lovisolo-Calossi Phakic IOL Sizing Software

helps to predict the expected clearances between different implant sizes and intraocular tissues.
3) The age of the patient (an average reduction of

the anterior chamber depth of 0.015 mm per
year is calculated to predict the behavior over
time).
Surgeons lacking access to expensive equipment,
such as VHF ultrasonography,205 a Scheimpflug
camera,37,71 or other technologies,152,258 may resort
to different regression analysis-based nomograms
taking into consideration the following variables:
white-to-white, anterior chamber depth, corneal
curvature, and irido-corneal angle width measured
with the Haag-Streit slit-lamp gonioscope165 (Potgieter FJ: Semi-quantitative assessment of sulcus diameter to
predictably achieve optimum vaulting of the Staar ICL.
Presented at the XVI ESCRS meeting, Nice, France,
September 1998). Once lens length has been
determined, because ICLs come only in 0.5-mm
step sizes so far, it is often necessary to round up or
down. In such cases (e.g., 12.75 mm) the overall
length is selected on the basis of the irido-corneal
angle width. For an angle larger than 0.7 mm, we
would round up (in this example to 13.00 mm) and
for one less than 0.7 mm we would round down (to
12.50 mm). However, in our experience, this
method has not improved our vaulting predictability
enough to significantly affect refractive accuracy and
provide optimal long-term safety.
SELECTION OF PATIENTS
Preoperative Examination
Regardless of the site of implantation, the guidelines recommended by the different manufacturers
about patient recruitment and preoperative work-up
agree that the candidate for a phakic implant must
have a thorough preliminary eye examination,
including clinical history, standard slit-lamp exploration of the anterior segment, gonioscopy, and
refractive measurements. Skiascopy, autorefractometry, automated and manual keratometry, best
spectacle-corrected visual acuity (BSCVA) at a vertex
distance of 12 mm are taken under miosis and
cycloplegic conditions. With high ammetropias,
a soft contact lens of known power and curvature
is often used, and the refractive measurements are
repeated. Then the following tests are always
required: an orthoptic examination, videokeratography and photographic measurement of the
horizontal white-to-white distance, endothelioscopy
(cell count and morphological indices), applanation tonometry, ultrasound central corneal pachymetry, A-scan echobiometry of the eye chambers,
mesopic infrared pupillometry, and, finally, a careful
examination of the fundus under complete mydriasis.21
568
Exclusion Criteria and Critical Parameters

Many of the usual exclusion criteria (Table 3) can
now be considered relative. Age, for instance, is not
an absolute preclusion to surgery. An original excess
of caution made it wise to avoid implanting phakic
IOLs in children, but special cases of unilateral
ammetropia or high anisometropia with contact lens
intolerance and functional strabismus are worth
reassessing, to prevent amblyopia.39,57,161,228
In certain cases, old contraindications have
proved too conservative, like in the case of stable
keratoconus and other ectatic corneal disorders,
such as pellucid marginal degeneration or trauma,
infection and sequelae from unsatisfactory previous
corneal surgeries (like PKP, LKP, RK, ALK, epikeratoplasty, LTK, PRK, LASIK).7,58,67,77,93,165,185,237
Ideal candidates are young, able to take full
advantage of the accommodation potential of their
natural lens, but have high ammetropia not correctable by excimer laser surgery and a problematic
relationship with spectacles and contact lenses.36,165
If we respect the widely accepted, although not
scientifically demonstrated, safety guideline of leaving a residual stromal bed of 250 mm or more,233
with average mesopic pupil diameter,55 corneal
thickness, and curvature, this means that the
implant surgery is indicated in myopic errors in
excess of 28.0 D and in hyperopic errors in excess
of 15.0 D.
Eyes with anterior chamber depth (ACD, endothelium to anterior crystalline central distance) less
than 2.8 mm and endothelial cell count less than
2,500/mm2 should be evaluated case-by-case and
TABLE 3
Widely Accepted Criteria for Implanting Phakic IOLs

Ages 21 to 50
General good health
Stable manifest refraction (6 0.50 diopter 6 months
apart)
Ammetropia not correctable with excimer laser surgery
Unsatisfactory vision with / intolerance of contact
lenses or spectacles
ACD (endothelium to anterior crystalline central
distance) $2.8 mm
Note: $2.5 mm for PRL
Irido-corneal angle aperture $30 (Shaffer grade 3 and
4234 or Scheie grade 0 and 1229)
Endothelial cell count O2,500 cells/mm2 at 20 years of
age
Endothelial cell count O2,000 cells/mm2 at 40 years of
age
No ocular pathology (corneal disorders, glaucoma,
uveitis, cataract, maculopathy, etc.)
No previous ocular surgery
taking into account age, IOL model to be implanted, and alternatives.

Measurement of the ACD has always been
considered an important guideline and is still
a medical-legal reference point. It is usually done
preoperatively at the slit-lamp with an optical device
(the Depth Measuring Device II, Haag-Streit, Switzerland21,165), by conventional A-scan ultrasound
biometry, or by laser partial coherence interferometry203,235 (IOLMaster, Carl Zeiss, Jena, Germany).
However, a single central distance is particularly
significant only for hyperopic eyes, but not for the
overwhelmingly myopic candidates, as there is no
precise correlation between central and mid-peripheral depths where the endothelium could be
damaged by intermittent contact with the edge of
the optic (Lovisolo CF: Sizing phakic IOLs. Presented at the ASCRS meeting, San Francisco, CA,
April 2003). Using VHF echotomography (Artemis
2) and scanning optical tomography (Orbscan
II)209,244 we realize that the majority of eyes show
a progressive narrowing from center to periphery
with the nasal regions about 20% shallower than the
temporal counterparts. However, some are strangely
shallower in the center. The deepest value is usually
obtained 0.3 mm temporally and 0.12 mm inferiorly
to the center of the pupil (it corresponds to an
average kappa angle of 5 ). In the area of critical
distance for myopic lens implantation (2.5--3.0 mm
eccentric to the pupil) the depth is reduced, on
average, by the following amounts: temporal 14%,
nasal 26%, superior 20%, and inferior 16%.
Moreover, each single eye seems to have its own
anterior chamber shape and volume, with no
general rule (Fig. 15).
In our opinion, for anterior chamber myopic
phakic IOLs, the most important measurement is
the mid-peripheral distance from the endothelium
to the thickest part of the lens, the edge of the optic
(2.5--3.0 mm of eccentricity). For posterior chamber
lenses, the geometry of the chamber and the
opening of the irido-corneal angle are critical issues
to ensure safe implantation.164
An optical tomographer like the Orbscan II,24 or
more sophisticated instruments like the EyeShape
interferometer (BioShape, Berlin, Germany), the
anterior segment optical coherence tomographer
(OCT-Visante, Zeiss), or the VHF ultrasonographers,210 whose scans provide point-by-point threedimensional maps of the geometric features of the
anterior chamber, could be used.21 However, these
are expensive devices, most of them depend on
skilled operators and highly cooperative patients,
because they need long measuring times for the
scanning as eye movements reduce the reliability of
measurements. At the moment, they still need to be
569
Fig. 15. The Orbscan images of a myopic (left) and a hyperopic eye (right) show completely different shapes and volumes
of the anterior chamber. Notice that similar mid-peripheral depths (about 1.9 mm at 3 mm of eccentricity) correspond to
significantly different central depths (3.8 mm [left], 2.6 mm [right]).
properly evaluated regarding accuracy of measurements in living eyes.

Age is a relevant factor, as the human lens
gradually grows, doubling its thickness and displacing anteriorly by 0.4 mm during the lifetime of a 90year-old,187 due to the life-long mitotic activity of the
sub-capsular epithelial cells at the lens equator. As
a consequence, the anterior chamber depth drops
by 0.75 mm over a 50-year span,94,108,187 particularly
in the periphery. It is thus essential to bear these
points in mind when dealing with very young
patients with shallow chamber volumes and flat
corneas, as is often the case in the hyperopic
patient. Nobody knows how much the anterior
chamber volume available to the aqueous circulation of a normal eye (average 157 ml) can be
reduced by the physical presence of an implant,
without risking angle-closure glaucoma. Long-term
effects of the redirection of aqueous flow have yet to
be determined, for posterior chamber phakic IOLs
in particular. One potentially useful figure is the
average central anterior chamber depth (1.84 mm)
and volume (95 ml)14,63,74,159,166 measured in eyes
with naturally occurring angle closure glaucoma.
In cases with doubtful biometric measurements, it
may be advisable to exclude surgery or to prefer less
vaulted models, like the Artisan/Verisyse or the
PRL. In hyperopic patients over 55 years of age,
particularly those with a narrow irido-corneal angle,
an almost general consensus would indicate that
phacoemulsification with in-the-bag IOL implantation may possibly be a safer choice and give a more
successful outcome.11,165
Age is an obvious factor for endothelial cell count,
too. The average 30-year-old undergoing phakic IOL
surgery has a mean endothelial count of 2,600 cells/
mm2. The physiological annual loss of 14 cells/mm2

reduces the count to 2,320 cells/mm2 at the age of
50, and to 1900 cells/mm2 at 80.165 To ensure
a minimum cell density of 1,000 cells/mm2 to the
eyes implanted with a phakic IOL at the statistical
time of cataract removal (around 70 years of age),
a safety calculation may be done by applying a loss
rate of 2.31% per year, the upper 90% confidence
interval of the average cell loss for eyes implanted
with the Artisan/Verisyse lens with anterior chamber
(including the corneal thickness) deeper than 3.2
mm. Starting from a minimum cell density of 3,500
cells/mm2 at 21--25 years, the following safety values
can be considered per age group: 3,175 cells/mm2
at 26-30 years; 2,825 at 31--35; 2,500 at 36--40; 2,225
at 41--45; and 2,000 cells/mm2 over 45 years.
However, as a consequence of cell centripetal
migration and enhanced metabolism after stopping
wearing contact lenses, a retrospective review of the
last 200 eyes operated showed that, after uneventful
surgeries, the endothelial cell count increased and
the morphological indices improved in 42% and
remained unchanged in 39% of eyes at 6 months
post-operation, independent on the type of foldable
phakic IOL implanted (Lovisolo CF: Complications
of phakic IOLs. Presented at the XXI ESCRS
meeting, Munich, Germany, September 2003). Only
a minority of cases (19%) showed a moderate
reduction of the cell count (from 1--4%) with
altered pleiomorphism and polymegatism indices.
These results are not consistent with the literature
that considers acceptable a moderate, although not
progressive, initial postoperative drop in endothelial
cell count. They would indicate that the concept of
intraoperative endothelial cell sacrifice needs to be
reviewed on the basis of age, IOL characteristics
570
(power, type, site of fixation) and individual biometric features of the eye to be implanted. Also, the
safety limits recommended by the companies (from
2,000 to 2,500 cells/mm2 of minimum cell density at
the time of implantation) appear to be excessively
dogmatic and not evidence-based.
Every phakic IOL candidate requires special
attention. Whereas the high hyperopes must be
carefully evaluated for their narrow intraocular
environment, eyes with pathological myopia must
be examined by a vitreo-retinal specialist to thoroughly assess the conditions of the posterior
segment, including indirect ophthalmoscopy with
scleral indentation under maximal pupil dilatation,
to detect zonular defects, which may predispose to
decentration or vitreous luxation of posterior
chamber phakic IOLs, or rhegmatogenous lesions
of the peripheral retina in particular. In some cases
fluorescein and/or indocyanine green angiography
may be helpful to document the macular conditions
and identify the risk of problems that are likely to
need treatment in later years.165
Until a full range of toric models is available, at
the moment only the ICL and the Artisan/Verisyse
lens have undergone clinical trials,77,107,116,171,224
associated astigmatism in excess of 1.00 D may
require corneal or limbal relaxing incisions, which
can be combined intraoperatively or completed at
a later stage.44,107,165 Second-step excimer laser
surgery is a valid alternative, like for myopic errors
in excess of 220.0 D. In Zaldivars Bioptics,260,265 the
surgeon waits for the small incision to heal
(approximately 30 days to make sure it will not
reopen under the stress of the suction ring) and
then performs LASIK surgery in the usual fashion.
To avoid the risks of touching the endothelial layer
(when an ACP-IOL is implanted) and dislocating
the lens during the suction and microkeratome
pass, the surgeon may opt for the ARS (adjustable
refractive surgery) to prepare the eye by making the
lamellar cut immediately before implanting the
IOL.115 After allowing at least 4 weeks for complete
refractive stabilization, the flap can be lifted and the
stromal bed photoablated to adjust the corneal
central curvature to the desired final refraction. To
avoid peripheral retinal traction during suction
activation and release, the surgeon may consider
PRK or LASEK to fine-tune the refractive outcome
in high myopic eyes.
variability of biological presentations, the variety of

anatomical shapes and sizes and range of optical
errors, the need for a custom-made lens implant
would appear even more obvious than personalized
corneal laser treatment.
Lenses that perfectly fit the individual anatomy of
each single eye are safer than conventional ones, as
late postoperative complications relate mainly to
unstable implants and less than ideal distances from
the internal structures.
Accurate preoperative assessment of the lens vault
height is vital to avoid concerns about endothelial
cell loss, cataract, and glaucoma from significant
aqueous flow disruption, anterior and posterior
synechiae, iris ischemia, and pigment dispersion.
The choice of overall length, central and peripheral
thicknesses of the optic, optic geometry (front and
base curve), and elasticity of the material will have
important repercussions, too.
With regard to efficacy and functional performance, the same concerns about the quality of
vision in kerato-refractive surgery apply equally to
phakic IOLs. To prevent the visual symptoms of the
GASH-tetrad syndrome (glare, arcs, starbursts,
halos), the optic should have the following:
1) The necessary sphero-cylinder power. This
calculation depends very much on precise
refractive measurements, but also on the ability
to predict the lens vault height, that is, the
intraocular position of the nodal points of the
lens (effective lens position, ELP). Refined
toric optics are currently available with Visian
ICL (Fig. 16) and Artisan/Verisyse lenses to
meet the needs of perhaps the most motivated
candidates for refractive surgery, highly astigmatic patients.7 Successful toric correction
requires an astigmatically neutral surgical
The Concept of Custom Phakic IOL

There is no doubt that the same concepts behind
the universal trend toward customization of corneal
refractive surgery could be immediately applied to
phakic IOL procedures. Considering the wide
Fig. 16.
The Staar Visian Toric ICL in situ.
incision and robust fixation site to provide

rotational stability over time. For that reason
the 6- to 7-mm opening of the eye needed for
implanting the rigid lenses may seem too
challenging for the average surgeon, while the
minimal size (2.8 mm) achievable in many
foldable models seems ideal. The rotational
stability238 of the implant is even more important, as the cylinder correction decreases with
increasing deviation of the implant from the
target axis by following a non-linear relationship. Because the PRL floats in the posterior
chamber, it is likely to continuously rotate
behind the iris, making astigmatic correction
impossible. As shown in a study where the
positions of a group of ICLs sized with VHF
echography were documented by superimposable slit-lamp photographs (Carlo Lovisolo,
unpublished data), the mean lens deviation
from the original meridian over time (3 years)
is less than 5 , that is, compatible with
a maximum of 10% loss of astigmatic correction. Once again, accurate sizing is mandatory.
2) An effective diameter, at least as large as the
mesopic entrance pupil diameter. Infrared
pupillometry has shown that scotopic pupil
diameter in myopic patients is significantly
larger than in the emmetropic group. Our
personal data on European patients support
those obtained by Chaidaroon and colleagues55
who reported, in an Asiatic myopic population,
a mean scotopic pupil diameter of 6.98 6 0.67
mm, the range of minimum-maximum value
ranging from 5.5 to 8.5 mm. For that reason,
due to the limited diameter of the optical zone,
all currently available phakic IOLs have been
reported to induce different degrees of nighttime visual disturbances (mainly halos and
glare when driving vehicles).176,239 As opposed
to what was measured in eyes implanted with an
ICL, which had a pupil dimension increased by
a mean of 0.2 mm,165 the eyes implanted with
an iris-fixated phakic IOL showed a decrease of
pupil size78about 1 mm on average, slightly
higher in the axis of enclavationwhich may
help limiting the visual disturbances generated
by the edge of the optic. The successful trend
of combining different surgical approaches
(Bioptics and/or Adjustable Refractive Surgery)115,260 has highlighted not only the concept of fine-tuning residual refractive errors
after implantation but also the need for a wide
functional optical zone. For a 217.00 correction in a patient with a 6.0-mm mesopic
pupillary diameter, for instance, postoperative
quality of vision is unquestionably better if we
571
select a wide-optic implant (a 212.00 ICL has

a 5.5-mm diameter and corrects approximately
210.00; a 210.00 iris-claw Artisan/Verisyse lens
achieves the same effective correction with an
optical zone of 6.0 mm and a safer distance to
mid-peripheral endothelium), and combine it
with a 27.00, 6.5-mm optical zone excimer
laser ablation, instead of implanting a 220.00,
4.65-mm optic ICL or a 216.00, 5.0-mm optic
Artisan/Verisyse correcting 217.00. As a trend,
the 7- to 8-mm optic diameter of the newcomer
lenses like Vision Membrane and ThinPhAc
(Table 2) makes it easy to foresee that the
average effective optical zone of future lenses
will soon be made larger.
3) A proper geometric shape factor (asphericity)
to respect physiology.173,191 Conventional highpower (more than 212.0 and 17.0 D of
correction) spherical phakic IOLs with an
average optic size of about 5.0 mm inevitably
result in significant spherical aberration in the
duophakic eye, thus increasing glare and halos
for the average mesopic pupil (Fig. 17).48
Although contrast sensitivity measurements
have been reported to improve at all spatial
frequencies in eyes implanted with an ICL if
compared to preoperative values,138 they remain below normal for high spatial frequencies.165 An aspheric phakic lens can be
designed on the basis of theoretical assumptions (to limit spherical aberration without
reducing the depth of focus132), or wavefront
analysis from aberrometers (to correct not only
on-axis aberrations like spherical aberration,
but also higher-order aberrations like trefoil
and coma). The weak point of aspherical lenses
is the need for perfect alignment with the
Fig. 17. Hartmann-Shack wavefront data (LadarWave,

Alcon, Forth Worth, TX, USA) three months after
uneventful implantation of a conventional 223.0 D 4.65
mm optic phakic IOL. Despite apparently optimal lens
centration on the pupil, high coma and spherical
aberration values with a 7.5 mm pupil caused significant
though non-disabling visual symptoms.
572
cornea and crystalline lens (centration and

tilt). When measured as a modulation transfer
function, the optical performance of an
aspheric IOL is only minimally degraded if
the IOL is decentered less than 0.4 mm and
tilted less than 7 .132,191 Larger discrepancies
between lens optical center and visual pathway
could cause significant symptoms. Our observations with infrared photography and VHF
echography on a group of patients implanted
with different phakic IOLs (I-CARE, Vivarte/
GBR, and ICL) showed that pupil decentration
is 0.32 mm and tilt is 5 on average (Carlo
Lovisolo, unpublished data). However, in patients with largely positive angle kappa,248 even
an accurate sizing of angle-supported and
posterior chamber phakic IOLs, whose fixation
depends on an even distribution of the
anatomical structures, could cause a significant
misalignment with the line of sight.153 Once
this becomes more accurate and standardized,
we can foresee a demand even for haptic
customization, with asymmetrical loops and
wings to match individual pupil decentration.
Otherwise, iris-fixated lenses that can be nicely
centered over the pupil will be preferred to
sulcus or angle-supported lenses.153
Similar concepts apply to the multifocal phakic,
the Vivarte Presbyopic/GBR NewLife, marketed by
Zeiss to cover the potentially widest market in
refractive surgery, the presbyopic patients.29 The
implant in fact has an aspheric optic (12.50 D fixed
addition, plus distance corrections from 15.0 to
25.0 D in 0.50 D steps) inducing a controlled
amount of spherical aberration to increase the
depth of focus and allow reading. Because a certain
amount of side effects are almost inevitable (reduced contrast sensitivity at different frequencies,
halos, glare),183 a precise evaluation of the angle
kappa and a preliminary trial with loose contact
lenses that simulate the implant optical geometry to
test the individual tolerance to the postoperative
quality of vision are highly advisable.
4) Quality of the surfaces higher than the eyes
optical limits, possibly designed or postoperatively modified on the basis of wavefront
detection. Eventually, the search for new
indications (to retreat complications and side
effects of previous surgeries in particular) takes
a well-trod path. Innovative technologies always
start overcautiously. As experience builds up
and the learning curve proceeds, many contraindications that seemed absolute become relative and are reviewed on a case-by-case basis,
sometimes even becoming elective indications.
Phakic IOL surgery could therefore be indicated for cosmetic purpose,190 in piggybacking pseudophakic eyes with significant residual
ammetropia,56 as well as in pediatric patients
with aniridia, albinism, anisometropic amblyopia, or in eyes with stable corneal disorders
(forme fruste keratoconus, marginal pellucid
degeneration, post-radial keratotomy or postLASIK visual errors, post-trauma or post-keratoplasty astigmatism), which cause significant
higher order aberrations and may theoretically
be tackled by making the compensating corrections intraocularly instead of on the corneal
surface. Note that once the implant position is
stabilized intraocularly, technologies like the
Light Adjustable Lens (Calhoun Vision, Pasadena, CA, USA) could possibly allow postoperative optimization of the eyes overall
aberrations through ultraviolet irradiation of
the photosensitive silicone polymer matrix.231
ND:YAG LASER PERIPHERAL IRIDOTOMY
One, if not two, preliminary Nd:YAG laser

peripheral iridotomies (PIs), well-patent, and sufficiently wide (at least 500 mm) 1--2 weeks before any
phakic IOL surgery have been recommended,16,162,165,240 to allow re-absorption of blood,
pigment, and inflammatory factors, or else an
intraoperative surgical iridectomy.124 The iridotomies should be classically positioned superiorly
(from 11 to 1 oclock), under the upper lid, to
avoid the risk of monocular diplopia or ghost
images, for esthetic reasons,1 and well away from
the haptics placement to prevent the pressure
on the ciliary body exerted by a haptic that ended
up in the iridectomy. However, on account of the
elastic properties of the acrylic material of the
modern flexible ACP-IOLs, the issue has become
controversial and some surgeons no longer consider
PIs or surgical iridectomy strictly necessary.29
PERIOPERATIVE MEDICATION
The patient is prepared, prepped, and draped as

for any routine intraocular surgery. To ensure
intraoperative comfort and reduce the post-operative reaction and risks, the following drugs are
commonly used:165
antibiotic eye drops (usually fluoroquinolones)
to prevent infection
benzodiazepine drops (10 mg of valium orally)
for sedation
5% povidone iodine solution for disinfecting
skin and conjunctiva
573
mydriatic eye drops (10% phenylephrine, 1%

tropicamide, and 1% cyclopentolate) to prepare the pupil for PCP-IOL implantation.
Preservative-free epinephrine can be injected
intraoperatively
miotic eye drops (2% or 4% pilocarpine) to
prepare the pupil for ACP-IOL implantation.
Some surgeons prefer the intraocular use of
preservative-free acetylcholine during the surgery in order to better control the center of the
real pupil
topical anesthetic eye drops (4% xylocaine,
0.4% benoxinate, proparacaine), intraocular
1% xylocaine and other anesthetic solutions
(2% mepivacaine, 0.5% bupivacaine) can be
used or injected depending on the surgeon
and/or patients preference
steroid (dexamethasone or fluorometholone)
and NSAID eye drops (sodium diclofenac or
similar) are administered postoperatively and
then tapered in 7--10 days
carbonic anhydrase inhibitors (acetazolamide
tablets) to prevent an excessive rise in IOP
loading in the cartridge/injector. The I-CARE lens is

folded in the cartridge with the four feet bent under
the optic. Then it is gently injected and completely
unfolds in the AC. The surgeon helps position the
lens by gently maneuvering with a hook or the
viscoelastic cannula through the side port.
The Vivarte/GBR lens cannot be injected, because of the rigid trailing loop. It is grasped and put
in a special folder then folded with a specially
designed forceps. Under viscoelastic protection and
pharmacological miosis, the Z-shaped knee is
inserted first into the AC. The folded lens is inserted
parallel to the iris plane and released. After
unfolding and withdrawal of the implantation
forceps, the single trailing haptic is placed in the
angle under the edge of the corneal incision, using
a hook. According to the manufacturers recommendations, the Vivarte/GBR lens must not be
rotated in the AC. The main incision is hydrated
with BSS and left sutureless.
The silicone optic of the Kelman Duet lens is
injected independently, then the tripod haptics are
inserted and clipped to an internal ring of the optic,
designed to hold them, and fixated in the angle.
Surgical Technique
ANGLE-FIXATED ACP-IOLS
IRIS-SUPPORTED ACP-IOLS
The actual procedure varies depending on the

kind of IOL to be implanted, rigid or foldable/
flexible. Both require pharmacological pupillary
miosis. Through a side-port incision, the anterior
chamber is filled with a cohesive OVD (sodium
hyaluronate or 2% hydroxypropylmethylcellulose).
Although Baikoff suggests a clear-cornea temporal
incision, some surgeons prefer a limbal or a sclerocorneal incision placed superiorly or on the steep
corneal axis. The optic of the rigid ACP-IOL is held
with a Kelman-McPherson forceps and carefully
pushed across the AC, until both ends of the trailing
haptic come to rest in the distal region of the angle.
A 5.0-mm silicone slide can be used to help protect
the iris and crystalline lens during the positioning
maneuvers. The dialing loop is then positioned in
the proximal region of the angle, using the onehanded technique with a Sinskey hook. The surgeon
checks that the pupil is round, and then performs
a superior peripheral iridectomy using Vannas
scissors or the vitrector. The incision is sutured with
two or three single sutures or three-bite, running
10-0 nylon; the viscoelastic substance is removed
and, with the gonioscope, the surgeon verifies the
correct positioning of the loops to make sure they
are not tucking the iris root.
Foldable ACP-IOLs can be implanted through
a self-sealing corneal incision. The most demanding
part of the procedure is the forceps folding or
The Artisan/Verisyse lens is implanted under

pharmacological miosis. Two 1.2-mm stab incisions
are made at the 10 and 2 oclock positions and
sodium hyaluronate is usually injected to fill the
anterior chamber. Although it can be placed on the
temporal or on the oblique side, the 5.5--6.5 mm
incision (limbal or sclero-corneal) is usually superior and this may be a limit in handling concomitant
astigmatism (oblique or against-the-rule). The lens
is grasped with curved holding forceps and inserted
through its smaller dimension (5.0 or 6.0 mm of the
optic), with the option of a protecting glide. Once
in the anterior chamber, it is rotated to a horizontal
position and centered to the pupil. While firmly
holding the lens with forceps, first a temporal midperipheral iris strip is enclavated with a special
needle or forceps, and then a nasal fold of iris is
gently pushed and caught by the claw.256 These
critical steps require skill and dexterity to capture
enough iris tissue to ensure lens stability. The
operation is completed with an iridectomy (if the
iris prolapses during surgery, this step should be
done immediately to facilitate repositioning of the
iris), the viscoelastic substance is removed and 10-0
nylon sutures are usually placed.
The flexible iris-claw ACP-IOL (the Artiflex/
Veriflex) is not folded, but stretches and flexes
through the incision, returning to its original shape
inside the anterior chamber when implanted with
574
an appropriate implantation spatula. Once the

spatula has been retracted, a cannula keeps the
lens steady by exerting counter-pressure on
the haptic rim. Then the lobster claws are enclavated in the usual way.
POSTERIOR CHAMBER PHAKIC IOLS
Injection Technique
The correct loading of the PCP-IOL in the
cartridge-injector is essential for easy implantation.
Using a modified McPherson forceps with long,
blunt, curved tips, the lens is carefully grasped and
checked under the microscope. The ICL has two tiny
holes on the footplates (distal-right and proximalleft) to indicate the anterior side. The current PRL
model, however, has no landmarks. In order to avoid
inverted implantation, the surgeon can make two tiny
dots on the haptics with a cautery, without damaging
the lens. The cartridge is partially filled and lubricated with a mixture of saline solution and viscoelastic
substance, to eliminate static forces. The lens can be
loaded with the dome convex-down (U-shape) or
dome-up (M-shape). A piece of soft material (Staar
Foam-Tip, a silicone sponge, or a wet piece of
Merocel) is positioned to protect the PCP-IOL from
contact with the plunger of the shooter. Broad
pharmacological mydriasis is obtained.
Two side-port incisions of about 1.0 mm are
created. A cohesive OVD is then injected (lowviscosity sodium hyaluronate, such as Healon, or 2%
HPMC, such as Ocucoat, is normally used), taking
care not to overfill the chamber. A 1.8--3.2 mm clearcornea temporal incision is made. The cartridge is
inserted bevel-down and must be rotated through
180 if the lens has been loaded U-shaped. During
delivery, the tip of the injector must not penetrate
too deeply inside the chamber, as would be normal
for the cataract surgeon implanting a foldable IOL
in the capsular bag. The lens moves along the
funnel in a cylindrical fashion and gradually unfolds
as it enters the chamber.
Forceps Technique
Many PCP-IOLs have been implanted worldwide
using one or two regular McPherson or similar
customized forceps. Manufacturers guidelines still
recommend this technique for implanting the PRL,
which is still marketed with no landmarks, like the
early ICL models. The main advantage of the
forceps technique is that the surgeon has almost
complete control over the unfolding procedure. He
can easily avoid implanting the lens upside-down.
However, there are drawbacks:
it requires a larger incision (3.5--4.0 mm)
it is technically more demanding

it carries a higher risk of intraocular trauma
The forceps technique can be used for reimplantation, once a phakic lens has been explanted
through an enlarged incision.
Retropupillary positioning of the footplates involves maneuvering the haptics through the side
ports, with a sandblasted visco-cannula or specifically designed "tuckers." Only a small degree of dialing
is acceptable and manipulations must be extraordinarily smooth and gentle.165 When posterior chamber positioning has been completed, because the
OVD must be removed as completely as possible,
bimanual I/A must begin under pupillary mydriasis
to allow the aspiration tip to reach the viscoelastic
substance trapped behind the lens. Then acetylcholine may be injected intraocularly to constrict the
pupil and the wound is hydrated.
Complications
The natural history of the average candidate for
phakic IOL implantation (the high myope) involves
a well-known risk of sight-threatening complications
during his or her lifetime, even though he or she does
not undergo surgery. In high myopic eyes the
incidence of retinal detachment is 40--100 times
greater than in the normal population,12,68,95,114
because of the posterior staphyloma, a distention and
atrophic thinning of the choroid and the sclera, with
various degrees of vitreous syneresis and posterior
detachment and consequently traction of the equatorial and peripheral retina. The same abnormalities
are behind the tendency to form macular puckers
and neovascular sub-retinal membranes. High myopic eyes are also well-known steroid-responders and
prone to developing chronic open-angle and pigmentary glaucoma. The age-related cataract appears
more early than the statistical average for the normal
population. Does phakic IOL surgery encourage
these naturally occurring phenomena? There is no
answer to this long-open question, because it is very
hard to predict whether, and when, these complications are likely to show up.12,17,155,163,192,216 On the
other hand, the prognostic scenario for high
hyperopic eyes does involve a significant risk of
angle-closure glaucoma, which is, however, easier to
predict on the basis of the preliminary biometric
measurements.14,63,74,94,104,159,166,209
INTRAOPERATIVE COMPLICATIONS
It is our opinion that intraoperative complications

are almost exclusively connected to human error in
the preliminary work-out (not done; not patent or
small iridotomies can cause intraoperative pupillary
block), in the anesthesiological modalities (peribulbar injections can cause bleeding or even perforate
the globe) or in the surgical technique, leading to
irreversible damage to the endothelium, iris, crystalline lens, or the phakic IOL.
Although it can happen with all models, inverted
implantation is a rare complication of PCP-IOLs.
With additional cautery marks on the PRL and the
latest models of ICL, intervening on the injector
before the optic has completely unfolded in the
anterior chamber easily prevents upside-down insertion. If, however, an inverted implantation does
occur, the surgeon must never try to turn the lens
round inside the anterior chamber, because of the
high risk of damaging the crystalline lens or the
corneal endothelium. The solution is to enlarge
the incision to 4.0 mm, remove the lens with specially
textured forceps under the protection of a viscoelastic substance, and reimplant it with appropriate
forceps. A suture may be required to ensure incision
tightness and astigmatic neutrality. The same technique should be used in the event of cataract surgery
or a phakic IOL exchange.64,135
POSTOPERATIVE COMPLICATIONS
Acute Glaucoma
Pupillary block is a common mechanism responsible for early acute glaucoma in eyes implanted
with a phakic IOL.16,52 It happens when, in the
retropupillary space, resistance prevents the physiological flow of aqueous through the pupil opening,
pushing forward the iris and closing the iridocorneal angle. Because the space between the
anterior crystalline lens surface and the posterior
pigment epithelium of the iris is very narrow indeed,
pupillary block is more likely to occur after PCP-IOL
implantation.
In these cases, because no correlation has been
found with VHF ultrasound and Orbscan optical
tomography between central, mid-peripheral depths
and irido-corneal angle aperture, (Lovisolo CF:
Posterior chamber phakic IOLs. ISRS/AAO 2003
Refractive Surgery comes of age. American Academy
of Ophthalmology, pp 33--41)21 we believe that
a minimal central distance between the endothelium
and the anterior crystalloid, as provided by the
manufacturers guidelines (ACD $ 2.5--2.8 mm),
gives only indirect and inaccurate information on the
more important safety parameters, the peripheral
depth of the anterior chamber and the width of the
irido-corneal angle. Nonetheless, surgeons should
stick to the manufacturers guidelines for medicolegal purpose, even if they seem too dogmatic.
Taking into consideration that, with a properly
sized myopic ICL, vaulted an ideal 350 microns, the
575
irido-corneal angle, as evaluated with the Orbscan, is

reduced by an average of 30% after implantation
(from about 42 to 29 165) and that the limit to risk
angle closure is classically put around 15 ,234
a minimal angle aperture $ 30 seems a more
reasonable guideline.
With Vivarte/GBR lenses, the manufacturers
claim that angle closure from pupillary block is
not possible, because of the forward movement of
the elastic acrylic optic in case of posterior thrust.
Therefore, although many surgeons worldwide
disagree, an iridotomy may be unnecessary.29
Malignant glaucoma is a potentially devastating,
although very rare, postoperative event where
a sudden, severe IOP rise is associated with nearabolition of the anterior chamber. The entire iridolenticular system is pushed forward and the aqueous
inverts its physiological direction (ciliary block),
moving towards the vitreous, where it forms pools of
fluid. Only a few cases have been anecdotally
reported after ICL implantation.150,165 If this happens, iridectomy is typically useless and miotics
worsen the situation, because the aqueous flow is
blocked posteriorly.121 If prompt medical therapy
with atropine and osmotic agents to dehydrate the
vitreous does not achieve results in a few hours, the
surgeon must intervene, removing the implant and,
in extreme cases, performing Chandlers procedure
(three-port pars plana vitrectomy and phacoemulsification plus IOL implantation).
When viscoelastic substance removal has been
incomplete, IOP rises because of transient trabecular
blockage by the residual viscous molecules (the
chamber is deep and the angle open) (Fig. 18). It
happens within the first 6--24 hours, and resolves
spontaneously in 24--72 hours. However, potentially
dangerous side effects, such as atonic pupil, may
occur and should always be prevented with appropriate medical therapy or by creating a slight decompression from the side-port incision in extreme cases.
An intermittent pupillary block occurring at night
after intraocular surgery causes the Urrets-Zavalia
syndrome.118,242 With no apparent symptoms, sudden ischemia from a steep IOP rise paralyses the
muscles of the iris sphincter, causing a blown pupil
in moderate mydriasis (around 7 mm) with direct
and indirect areflexia. The wide atonic pupil causes
the mesopic visual symptoms induced by the edge of
the optic. It is often irreversible and will not respond
to pharmacological treatment. Phakic IOL removal
will not change the situation to any degree and
disappointing results have been reported after
pupilloplasty with Mersilene 11/0 purse-string suture,165 given the atrophic fragility of the iris stroma.
If the patient does not complain about these
problems, the surgeon should leave the lens inside
576
Fig. 18. Differential diagnosis of acute IOP rise after posterior chamber phakic IOL surgery. Pre-trabecular block caused
by retention of viscoelastic substance. The chamber is as deep and the lens as vaulted as expected (top left). Pupillary
block: the anterior chamber is deep but exaggerated lens vaulting pushes the iris forward to cause angle closure (top
right). Malignant glaucoma: the chamber is shallow, with both the crystalline lens and the PCP-IOL pushing forward
(bottom).
the eye, possibly widening the iridotomies (re-YAG).

A phakic IOL exchange with the newest wide-optic
models or a clear-lens extraction with implantation
of a low-power wide-optic IOL in the capsular bag
are possible alternatives.
High-dose postoperative cortisone in a recognized
steroid-responder population almost invariably creates a gradual but considerable steroid-related IOP
rise, which always subsides to the preoperative values
with the suspension of treatment, 2--4 weeks after
surgery, but sometimes requires topical therapy with
beta-blockers. Today this should no longer be
a problem, because the duration of post-surgical
anti-inflammatory therapy has been greatly reduced.
Chronic Glaucoma and Uveitis
Due to the surgical trauma (including the preliminary iridotomies) and the prolonged contact
with the trabecular meshwork and iris root (angle
fixation), mid-peripheral iris stroma (iris support)

and posterior iris epithelium (posterior chamber
IOLs), some degree of erosion, vessel disturbance,
pigment dispersion, and synechiae formation is
inevitable after phakic IOL implantation, hence
the concern about pigmentary dispersion syndrome
(PDS)-glaucoma,46,53,140 iridocyclitis, and breakdown of the blood--aqueous barrier. Although
moderate evidence of pigment loss (window iris
defects with transillumination and trace deposition
in the trabecular meshworka small inferior
Sampaolesi line)2 can often be seen after phakic
IOL surgery, a few sporadic cases of true pigmentary
glaucoma with postoperative elevated intraocular
pressure, Krukemberg spindles, and dense pigmentation of the trabecular meshwork,45 which occasionally required filtering surgery,221,263 have been
described after posterior chamber phakic IOL
implantation. In general, phakic IOL surgery leads
577
to a slight and transient increase of the IOP during

the first months after surgery, then the IOP
returned to preoperative baseline.3,165 Transient
low-grade acute postoperative iritis has been observed in 3.4--10.7% of cases after anterior chamber
(both iris and angle-supported) implant surgery.9,10
With regard to the long-term inflammatory response within the eye, the evidence to date appears
to support the safety of phakic IOLs, although
fluorophotometric evaluations in eyes implanted
with Baikoff and Worst ACP-IOLs are controversial,
as some reports indicate a prolonged breakdown of
the blood-aqueous barrier and a reduction in the
transmittance of the crystalline lens.40,197 In a preliminary study run in 1997, iris fluorangiography of
12 eyes implanted with an ICL showed limited dye
leakage from the vascular trunk of the iris in the
early postoperative period, and it had disappeared 3
months after surgery.165 In a study including more
than 500 ICL-implanted eyes, clinical flare and
cellular reaction was reported as absent in 99.6-100% of cases. In a small subset of the study
participants who were tested with the laser flare
and cell meter, measurements taken between 3
months and 3 years after surgery were within the
normal range.222 There is hope that the improvements of thinness and biocompatibility of current
lens implants will limit the mechanical chafing to
moderate and self-limiting pigment dispersion that
will never reach a level of clinical importance.165
Iatrogenic iris pathology resulting in pupil ovalization and iris stroma subatrophy from prolonged,
excessive compression of blood supply by oversized
lenses or over tightening claws (some authors think
that such complications with angle supported IOLs
are inherent to the fixation system itself) seems to be
the major concern of actual anterior chamber
models (Fig. 3). In fact, if severe cat-pupils
secondary to iris tucking from inappropriate surgical
positioning of the haptics are excluded, and the
smaller degrees of pupil distortion after anglefixated phakic IOL implantation are considered,
there is some reasonable concern that the complications percentages, ranging from 5.9 to 16.2%, 10
are going to increase in the future. Although some
variable degree of pupil changes (reduced reactivity
time and amplitude, prolonged latency and duration
of pupil constriction) have been registered147,165
after posterior chamber phakic IOL implantation,
these have not proved to be clinically significant to
date.
Infection
Endophthalmitis can complicate any open-eye
procedure. However, the literature offers only
anecdotal reports of septic intraocular inflammation

after phakic IOL implantation,165,200 with an exceedingly low incidence that can be roughly
estimated at one case in 8,000. Compared to cataract
surgery, the severity of the complication could be
limited by the maintenance of the crystalline lens
barrier, which may delay the catastrophic spread of
the infection to the vitreous chamber.165
Cataract
Iatrogenic crystalline lens opacification may be
caused by excessively traumatic surgery. Experience
has shown that only very delicate (butterfly-like)
intraoperative contact with the crystalline lens is
without consequences. Any rough, aggressive maneuvers can cause immediate focal opacity or
spread progressive anterior cataracts, showing up
from 3 weeks to 6 months after surgery.165 Another
cataractogenic factor associated with vitreo-retinal
surgery, air bubbles, must be meticulously avoided.
A cohesive OVD that tends to adhere to itself and
is easily removed, such as sodium hyaluronate,
should always be used to help the surgeon by
maintaining the intraocular spaces and it must be
thoroughly removed. A dispersive OVD, like the
sodium hyaluronate 3.0%-chondroitin sulfate 4.0%
(Viscoat, Alcon, Forth Worth, TX) should not be
used, as it may induce changes in lens epithelial
cells.49
Postoperative minor trauma184 and inadequate
medical treatment is another potential cause of
cataract formation, for instance, an excessive postoperative steroid regimen. Apart from these conditions and despite significant rates are reported for
angle-supported phakic IOLs (3.42% incidence of
nuclear cataract at 4 years average, 8 years maximum
follow-up),6 the question of a cataract-stimulating
role of phakic IOLs is awaiting judgment above all
for the PCP-IOLs, sandwiched in a narrow space so
close to the anterior lens surface.46,64,83,220
On the topic of etiology, until a few years ago it
was believed that the hydrophilic nature of the
collamer was crucial for avoiding cataract formationthe exact opposite of what happens with
hydrophobic silicone.165 Now more attention is paid
to proper sizing of the PCP-IOL, to achieve
adequate vaulting, or rather, a big enough space
between the IOL and the crystalline lens to leave the
latter undisturbed. Given the aspherical shape of
the anterior crystalline lens surface and the optic
geometry, the vaulting of myopic lenses is reduced
peripherally, especially when higher powers and
thicknesses are involved. If the overall length of the
PCP-IOL is short, the optic edges make mechanical
contact to the semi-peripheral regions of the
578
crystalline,104 thus preventing adequate aqueous

circulation and causing subcapsular opacification.
This theory is confirmed by the fact that, to date,
very few hyperopic ICL-induced opacities have been
reported, even if in these short eyes the implant is
closer to the crystalline lens. The geometry of the
hyperopic optic is such that aqueous circulation is
not impaired.165 We recently presented preliminary
outcomes of new ICL-models with four oblique
symmetrical thru-channels, 0.6 mm in diameter,
placed close to the optic edge (Lovisolo CF: Custom
ICL. Presented at the VIII ESCRS Winter Meeting,
Barcelona. Spain, January 2004). They were engineered to allow physiological flow of nutrients to
crystalline lens by ensuring a uniform aqueous
pressure on both sides of the holes, to prevent
IOP rise because of the implant presence (pupillary
block), to decrease the implant stiffness, and to
safely improve intraoperative handling by inducing
no significant change in ICL vault height (axial
displacement).
The issue of potential intermittent touching
during accommodation,104 when the crystalline lens
moves forward, was recently addressed with partial
coherence interferometry studies.203 As the sulcus
retracts with accommodation no significant changes
in distance between the ICL and the crystalline lens
were found; the ICL vaulting increases as necessary,
compensating the 200- to 600-mm forward movement of the anterior lens surface. On the other
hand, under photopic environmental conditions or
after application of pilocarpine, pupil constriction
reduces the vault height by forcing the ICL against
the crystalline lens.203
The rate of iatrogenic cataract ranges from 0.82%
(for the PRL)76,253 to 4.38--12%220,224 at 1--5 years
for the previous version of ICL. In our most recent
personal series on 494 eyes implanted with the ICL
V4 since April 1998, with a mean follow-up of 37
months (Lovisolo CF: Posterior chamber phakic
IOLs. ISRS/AAO 2003 Refractive Surgery comes of
age. American Academy of Ophthalmology, pp 33-41), we have not yet observed any cases of iatrogenic
cataract. While recognizing that researchers are still
far from fully understand the detailed mechanisms
of cataract formation, we attribute these results to
the precise sizing of the implanted lenses, allowing
a precise prediction of ideal lens vaulting.
Once bilensectomy in the duophakic eye (phakic
IOL plus cataract removal) becomes necessary,
a mathematical correction to the axial length (AL)
measurement obtained with ultrasound or optical
devices must be made to obtain an accurate
calculation of the dioptric power of the IOL to be
implanted.123 For A-scan US biometry, Hoffer122,125
suggests the following formula:
CAL5AL1X3T
where CAL 5 corrected axial length, AL 5 axial
length obtained with an average US speed of
1,555 m/sec, X 5 correcting factor, T 5 central
thickness of the phakic IOL
Central lens thickness T should be provided by
the manufacturer or measured with VHF ultrasound
device. The correcting factor X depends on the
material of the lens implant (Hoffer122 gives the
following values: X 5 0.42 for PMMA, X 5 0.23 for
acrylic, X 5 0.11 for collamer, X 5 20.59 for
silicone).
Corneal Decompensation
In view of the high rates of corneal decompensation reported after the first implantations33,97,101
and assuming that the phakic lens would be kept
into the eye until natural cataract developmentan
average functional life of about 40 yearsmaximum
long-term preservation of the corneal endothelium
is an obvious core issue for the entire area of phakic
IOL implantation. The intraoperative sacrifice of
a certain amount of endothelial cells (between 2.1%
and 7.6%) depends largely on the surgeons
experience and is generally accepted as inevitable.
The main concern is the likelihood of further
ongoing cell loss through intermittent mechanical
contact with the anterior chamber IOL, which must
be prevented by ensuring a minimum recommended clearance of 1.5 mm between the endothelium
and the thickest portion of the anterior chamber
lens, the edge of the myopic optic (Table 1). This
critical mid-peripheral distance must be carefully
established preoperatively by performing accurate
biometric measurements. The majority of ACP-IOL
studies rate cell loss at three months and one year at
about 7%, no greater than after modern cataract
surgery. Alio10 reports the longest follow-up of
angle-fixated lenses. After 7 years, the cell loss was
9.6% with the ZB5M. With the Artisan/Verisyse lens,
the loss ranged between 9.6% at 3 years50 and 17.6%
at 2 years.196 The recent results of the prospective
clinical trial including the first 765 eyes enrolled at
the FDA sites and implanted with a myopic Artisan/
Verisyse IOL, a percentage cell loss was 0.09 6
16.39% at 6 months, 0.87 6 16.35% at 12 months
and 0.78 6 17.41% at 24 months was found, with no
statistically significant postoperative change from
baseline.204
The iris barrier between the posterior chamber
IOL and the cornea should protect against this
feared complication, although some doubt has been
raised.136,172 In a series of 34 patients implanted
with an ICL, Dejaco-Ruhswurm and coauthors
579
reported a progressive loss with rates ranging from

5.5% at 1 year, 7.9% at 2 years, 12.9% at 3 years, and
12.3% at 4 years during a 4-year follow-up,73 thus
suggesting a non-contact, inflammatory mechanism
for endothelial cell deprivation. However, only the
first-year data were statistically significant and the
cell morphological indices (polymorphism and
polymegathism) remained stable during that period. Moreover, our personal experience on 12
anisometropic patients implanted with the ICL in
one eye and evaluated for 8 years (the fellow eye was
used as control) showed a loss rate similar to that
due to physiological aging (about 0.7% per year)
(Carlo Lovisolo, unpublished data).
It is important to keep in mind that endothelial
issues are controversial and evoke substantial debate
(Food and Drug Administration Ophthalmic Devices Panel, report of the 107th meeting, Feb 5, 2004).
Is 0.6% the normal cell loss rate due to aging? What
is the lowest count for concern? Should we remove
the phakic IOL on the basis of a certain progressive
loss (for instance, a deprivation greater than 50% of
the cell patrimonium) or of an absolute value (i.e.,
a cell count lower than 1000--1500 cells/mm2)? Does
corneal integrity depend on the absolute number of
the endothelial cells or on their real functions? How
many patients have we seen with endothelial cell
dystrophy and progressively decreasing densities
that did not decompensate over the years? Do we
need other indices (thickness, morphology)? Are
the actual methods of examination reliable? How
many variables do affect evaluations and changes?
No definitive answer is available. At minimum,
patients should be asked not to rub their eyes and
to periodically repeat specular or confocal microscopy to check the behavior of the endothelial layer
quantitatively and morphologically.
Posterior Segment Complications
In high myopia (over --10.0 D), the natural history
of the first 60 years of life (before ARMD age)
carries a significant risk of retinal detachment and
macular pathology (respectively, 2.4% vs. 0.06%,
and 6% vs. 0.002% in the normal population).68,114,217 Phakic IOLs may affect the posterior
retina through a mechanism of acute (intraoperative trauma) or chronic inflammation that extends
from the iris or the ciliary body to the posterior
uvea, to cause cystoid macular edema.5,105,198
As far as it is known, vitreous hemorrhages,186
choroidal neovascularization,217 and ischemic optic
neuropathy195 are scantly reported after anterior
chamber phakic IOL implantation in high myopic
patients. The cumulative risk does not seem to
increase significantly. Also, a few cases of retinal
detachment have been anecdotally reported in

subjects implanted with a phakic IOL, some of
them with giant tears and an avulsion of the
corresponding vitreous base.12,155,165,213 Excessively
aggressive YAG-PI or rough surgical maneuvers
causing intraoperative loss of anterior chamber
depth with a pressure gradient and forward movement of the vitreous body may disturb the vitreous
base, influencing traction in an already predisposed
posterior segment. Maintenance of the anatomical
separation between the posterior and anterior
segments of the eye should protect from severe
vitreo-retinal complications. Decompartimentalization of the eye, with the creation of a connection
between the two segments after Nd:YAG capsulotomy, requires a series of events (iatrogenic or
natural cataract, phacoemulsification, posterior capsule opacification, laser capsulotomy, endophthalmodonesis with vitreous traction) eventually leading
to retinal detachment. Episcleral buckling procedures can cause anterior displacement of the ciliary
bodies and crystalline lens, reducing anterior and
posterior chamber volume230 and simulating the
clinical condition called plateau iris syndrome
when an IOP rise is caused by an inverse pupillary
block without angle closure.165 Compressing
buckles may impair choroidal venous drainage and
cause edema of the ciliary body. In these cases, once
we decide for a phakic lens implantation, an ACPIOL may be preferred to a PCP-IOL.
Our personal experience confirms that the
presence of a phakic lens implant does not prevent
good pupil dilation for observation of the retinal
periphery, the execution of fluorangiographies and
even complex surgeries like posterior vitrectomy
and macular translocation.117 However, on account
of the internal thrust if gas is injected into the
vitreous chamber and the need to keep the prone
position that could displace the lens, the surgeon
should consider the possibility of explanting the
IOL, and eventually reimplanting it.
The vitreo-retinal surgeon may have to tackle the
complications of phakic IOL surgery. The surgeon
has an important role in providing documentation and in the prophylaxis of any pathology
before surgery, and the treatment of postoperative
problems.
Phakic IOL Dislocation
Both anterior chamber and posterior chamber
phakic IOLs can luxate. Small angle-fixated lenses
rotate and should be replaced with longer ones. Irisfixated lenses may subluxate spontaneously in case
of poor iris attachment or ocular or head trauma.201,259 PCP-IOL decentration is more common
580
with PRL than with properly sized ICL, as the only

two sizes available do not always fit big eyes
well.135,212 Vitreous displacement of the PRL has
been reported at meetings in numerous cases
(Lovisolo CF: Posterior chamber phakic IOLs.
ISRS/AAO 2003 Refractive Surgery comes of age.
American Academy of Ophthalmology, pp 33--41).
Unrecognized zonular incompetence, excessive surgical trauma or an etiologic role of the shape and
contour of the PRL haptics, which cause progressive
erosion of the zonules are suspected.
Competitive Analysis
A self-sealing, sutureless, small (less than 3.5 mm)
incision is an unquestionable advantage of the
foldable PCP-IOLs and ACP-IOLs over the rigid
PMMA implants, which require 5.5--7.0-mm incisions.
These procedures have greater anesthesiological
needs; they carry greater intraoperative difficulties
and risks of early inflammatory reactions, infection
and endothelial cell loss. Nevertheless, the main
problem is the difficulty of managing astigmatism.
Late, intermittent, or subchronic inflammation is
more frequent with the angle-fixated ACP-IOLs,
often leading to pupil distortion and haptics
entrapment by fibrotic gonio-synechiae.
If we consider bilensectomy the inevitable fate of
every duophakic eye, which sooner or later will
develop cataract for natural or iatrogenic reasons,
the ease of removal of the lens through a small
incision can make all the difference when lens
exchange or phacoemulsification becomes necessary. Strong synechiae and the large incision
necessary to remove a rigid IOL can jeopardize the
surgical procedure. In PCP-IOL implanted eyes, no
synechiae have been described, although further
follow-up is obviously needed to confirm the ease
with which these lenses can be explanted through
a small incision. The challenging calculation of
proper IOL power has already been discussed.122,125
Nighttime symptoms are caused by the optic size
not matching the mesopic pupillary diameter and/
or intraocular reflections.176,239 The incidence of
glare and halos ranges from 23.4--100% and is far
lower for 6.0-mm optic lenses and eyes with small
pupil diameters.103 The difference in maximum
effective dioptric correction achieved by the various
models is not significant. The maximum power
available with the ICL corrects significantly less than
the other models (about 218.50 versus an average
223.0 with ACP-IOLs and a maximum of 228.0 with
the PRL), but the firm (Staar Surgical) can now
supply special powers to prescription.
Esthetically, the early effects (patched eye, bruising, swelling of the eyelid, etc.) are connected more
with the type of anesthesia than with the type

of implant. However, the cosmetic appearance of
ACP-IOLs (those in PMMA in particular) can be
a problem to certain patients, who may prefer PCPIOLs, which are completely invisible to the naked eye.
In the long run, the risk of endothelial decompensation is higher for ACP-IOLs than for
PCP-IOLs, thus balancing the lower risk of cataract.
The risk of early glaucoma complications seems to
be the same. However, pigment dispersion would
appear to be greater in eyes implanted in the
posterior chamber, for anatomical reasons (the
small distance between the lens and the posterior
pigmented layer of the iris).
Future Developments and Conclusions

We can roughly estimate that around 70,000
phakic IOLs (equally divided among angle-fixated,
iris-supported, and PCP-IOLs) have been implanted
to date throughout the world. The international
ophthalmic community largely agrees that progress
is still needed on several points:
1) The surgeons learning curve and experience
in sorting out intraoperative difficulties
2) The biocompatibility of the material
3) The lens design in order to achieve adequate
vaulting, or at least to leave the edge of the
optic at a safe distance from the endothelium
and from the crystalline lens
4) The smooth, uniform distribution of minimal
pressures at the fixating points without losing
intraocular stability
5) The performance of the optic (fine quality of
the surfaces, physiological geometry and diameter wide enough to match the patients
scotopic pupil diameter)
6) The lens sizing, to improve the stability of the
implant
When these aims have all been achieved, current
minimally invasive techniques of phakic IOL implantation are likely to produce excellent results in
terms of precision, predictability (the percentage of
eyes obtaining 61.00 D from the desired refraction
will soon be close to 100%), and stability of the
refractive outcome, with acceptable postoperative
complication rates.
Transient uveal reactions with postoperative inflammation (2--13% in the literature)5,198 and IOP
rises (7--29%) occur with ACP-IOLs, but they
respond well to conventional therapy. The rates of
IOL dislocations (0--18%), glaucoma (0--21%), and
pupil deformations (6--18%)10,110,194,245 are due
mainly to human errors in sizing and surgical
maneuvers, so they can be expected to become less
581
frequent as surgeons gain experience. The incidence of catastrophic events like endophthalmitis
(only anecdotal reports) and retinal detachment
(0.6--4.5%)12,155 is acceptably low if considered in
the balance of the risk/benefit ratio of a population
naturally prone to posterior segment diseases. Time
will tell us whether prevalence will rise and the riskbenefit balance will modify as technology moves
down into the lower levels of ammetropia.
Nighttime visual symptoms (halos, arcs, and
glare) are very frequent (6--72%) but are disabling
only in a minority of cases. They are destined to
become minor issues with the latest and future
generations of wide-optic lenses. With adequately
sized current models of PCP-IOLs, iatrogenic
cataract should become avoidable too.
However, we must emphasize that it is not certain
whether these short-term reassuring features will
apply to phakic lenses in the longer term. Because
the implant is generally inserted into young
patients eyes, it must theoretically stay in a harmonious relationship with the internal structures with
no optical and physical decay of the material,
probably for at least 30 years, if not life-long. The
absence of synechiae and chronic inflammatory
phenomena encapsulating the haptics will facilitate
future IOL exchange or the bilensectomy procedure
when the time comes for cataract surgery in these
subjects. The widespread clinical applications of
PMMA and non-PMMA implants (collamer, silicone,
hydrophobic, and hydrophilic acrylic) have given
enough proof of biological compatibility35,69 and
the endurance of properties like elasticity and
permeability to gases and nutrients.146
With time, we must remain aware of the unknowns
involved in the lasting anatomical-functional integrity of the endothelial layer (with corneal decompensation as a major risk), of the anterior uvea (chronic
uveitis, irreversible ovalization of the pupil, iris subatrophy, and pigment dispersion), of the iridocorneal angle structures (with glaucoma as a worstcase scenario, particularly for eyes with a reduced
anterior segment, as is often the case in severe
hyperopia), and of the crystalline lens (with cataract
extraction, posterior capsule opacification, laser
capsulotomy, and final eye decompartimentalization
carrying the risk of facilitating the onset of invalidating vitreo-retinal complications in high myopes).167
As usual, only time will be the judge through further
studies and experience.80,136,143,149,151,249
Method of Literature Search

The authors conducted a search of the MEDLINE
database (1960--2003) using the search words phakic
IOL, high myopia surgery, lenses, corneal pathology,

intraocular lenses, refractive IOLs, hyperopia surgery, iris
pathology, crystalline lens physiopathology, and power
calculation. All articles judged to be of clinical
importance were included, and priority was given
for reports of large series and long follow-ups. The
search was updated during the review process to
include key articles published after the article was
submitted. Peer-reviewed journal articles were cited
when available, but in cases where that was not
possible, other sources of information such as
personal data, meeting abstracts, and so on, were
cited.
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Dr Lovisolo reported no proprietary or commercial interest in

any product mentioned or concept discussed in this article. Dr
Reinstein has a financial interest in the Artemis VHF digital
ultrasound scanning technology (Ultralink, St. Petersburg,
Florida).
Reprint address: Carlo F. Lovisolo, Quattroelle Eye Center,
20121 Via Cusani 7/9 Milano, Italy. e-mail: loviseye@fastwebnet.it.

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Phakic Intraocular Lenses

All in-text references underlined in blue are linked to publications on ResearchGate,

Available from: Dan Z Reinstein

VOLUME 50 NUMBER 6 NOVEMBERDECEMBER 2005

DIAGNOSTIC AND SURGICAL

Phakic Intraocular Lenses

image quality. Because the cornea is responsible for

0039-6257/05/$--see front matter

Surv Ophthalmol 50 (6) November--December 2005

LOVISOLO AND REINSTEIN

than eyes implanted with a posterior chamber

PHAKIC INTRAOCULAR LENSES

Fig. 1. Artists remake, from the original drawings, of the

was subsequently called the UGH-syndrome (uveitis-glaucoma-hyphema).35,82,148

Surv Ophthalmol 50 (6) November--December 2005

Unfortunately, 3 years later at least 10% of these

LOVISOLO AND REINSTEIN

In 1997, the third generation of rigid Baikoff

PHAKIC INTRAOCULAR LENSES

Distances to Endothelium of Different Anterior Chamber Myopic Phakic IOLs

lengths of 12.3, 12.8 and 13.3 mm (McGrath D:

12, 12.5, Not yet Van der

12, 12.5, Not

LOVISOLO AND REINSTEIN

Surv Ophthalmol 50 (6) November--December 2005

Summary of Current Angle-fixated AC Phakic IOL Models

? 5 Not disclosed as confidential by the manufacturing company.

PHAKIC INTRAOCULAR LENSES

Summary of Current Iris-supported AC Phakic IOL models

LOVISOLO AND REINSTEIN

Surv Ophthalmol 50 (6) November--December 2005

Summary of Current Posterior Chamber Phakic IOL Models

23 to 221 / 11.5, 12, 12.5, 3-year clinical

0.10 / 0.23** 0.30 to 0.50

23 to 220 / 10.8, 11.3

13 to 115 / 10.6 (H)

Surv Ophthalmol 50 (6) November--December 2005

LOVISOLO AND REINSTEIN

Fig. 4. The GBR/Vivarte foldable angle-fixated phakic

steps/rings 50 mm in height, each with a slightly

Fig. 5. The I-CARE foldable angle-fixated phakic IOL

PHAKIC INTRAOCULAR LENSES

61.0 D). At 1 year, the percentage of endothelial

(3--5%) and over time the mean cell change does

Surv Ophthalmol 50 (6) November--December 2005

LOVISOLO AND REINSTEIN

the pupil was unable to constrict beyond 4.0 mm.

POSTERIOR CHAMBER PHAKIC LENSES (PCP-IOLS)

In 1990, after the collar button lens, the project at

In the short term, the most frequent complications

PHAKIC INTRAOCULAR LENSES

ultra-thin hydrophobic silicone with a refractive

in myopic lenses it starts with a large-radius convex

Surv Ophthalmol 50 (6) November--December 2005

The edge thickness is always less than 0.2 mm. It is