Visual and Patient-Reported Outcomes

of a Diffractive Trifocal Intraocular Lens

Compared with Those of a Monofocal
Intraocular Lens
Satish Modi, MD, FRCS(C),1 Robert Lehmann, MD,2 Andrew Maxwell, MD, PhD,3 Kerry Solomon, MD,4
Robert Cionni, MD,5 Vance Thompson, MD,6 Jeffrey Horn, MD,7 Michael Caplan, MD,8 Bret Fisher, MD,9
Jerry G. Hu, MD,10 Elizabeth Yeu, MD11

Purpose: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort
Worth, TX), versus a monofocal IOL, the SN60AT (Alcon).
Design: Food and Drug Administrationeapproved, prospective, multicenter, nonrandomized, parallel-group,
assessor-masked, confirmatory trial.
Participants: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with
planned removal by phacoemulsification with a clear corneal incision.
Methods: Consented participants selected their preferred IOL, which was implanted sequentially into each
eye of patients meeting eligibility criteria.
Main Outcome Measures: The coprimary effectiveness outcomes were mean photopic monocular best-
corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6
months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected
intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding “never” to question 1 of
the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety
outcomes included frequency of “severe” and “most bothersome” visual disturbances.
Results: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the
TFNT00 (n ¼ 129) or SN60AT (n ¼ 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in
mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the
minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of
0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion
of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respec-
tively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less
than 5% of patients were very bothered at month 6.
Conclusions: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL,
with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (þ0.5 D to
e2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the
photic visual disturbances associated with the TFNT00 at 6 months after surgery. Ophthalmology 2021;128:197-
207 ª 2020 by the American Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

The incidence of cataract rises with each decade of life from dependency in recipients,5 with studies reporting relatively
40 years of age onward, with a prevalence of 68.3% low levels of overall patient satisfaction and perceived
reported for United States adults 80 years of age and older,1 quality of life.6 Multifocal IOLs have more than 1 focal
and the overall prevalence in the United States population is point to provide vision over a range of distances, reducing
predicted to double to 50 million by 2050.2 The current the frequency of spectacle dependence in comparison
standard-of-care treatment for cataract is small-incision with monofocal IOLs.5e7 However, this comes at the
phacoemulsification with foldable intraocular lens (IOL) cost of reduced contrast sensitivity and increased photic
implantation.3 Monofocal IOLs are designed to focus light phenomena.4,5,8e12 In addition, some multifocal IOLs have
on a single focal point, facilitating distance vision; been associated with compromises in either intermediate or
however, their lack of accommodation for near and near vision.13 In an attempt to address this issue, a method
intermediate distances4 leads to a high level of spectacle of blended implantation involving implanting a multifocal

ª 2020 by the American Academy of Ophthalmology https://doi.org/10.1016/j.ophtha.2020.07.015 197

This is an open access article under the CC BY-NC-ND license ISSN 0161-6420/20
(http://creativecommons.org/licenses/by-nc-nd/4.0/). Published by Elsevier Inc.
 Ophthalmology Volume 128, Number 2, February 2021

IOL in one eye with an intermediate focus point and a consent was obtained from all patients. Inclusion criteria included an
multifocal IOL in the contralateral eye with a near focus age of 22 years or older; diagnosis of bilateral cataract with planned
point aims to extend range of vision.14 Although blended removal by phacoemulsification with a clear corneal incision, clear
implantation of multifocal IOLs can improve overall range intraocular media other than cataract, a projected best-corrected
distance visual acuity (BCDVA) of 0.20 logarithm of the mini-
of vision for patients, evidence suggests this approach
mum angle of resolution (logMAR) or better, a calculated lens power
provides no significant advantage in terms of visual acuity within the available range (15.0e26.5 D), and preoperative regular
compared with bilateral implantation of the same lens15 or keratometric astigmatism of less than 1.00 D in both eyes. Exclusion
unilateral implantation of a single multifocal IOL.16 criteria included clinically significant corneal abnormality, disease,
Diffractive trifocal IOLs are designed with 3 optical focal or degeneration that could affect postoperative visual acuity;
points to provide functional distance, intermediate, and near previous refractive surgery or corneal transplantation; any ocular
vision.17e19 The AcrySof IQ PanOptix (model TFNT00; pathologic features or degenerative disorders that could
Alcon, Fort Worth, TX) is a nonapodized, single-piece affect postoperative BCDVA; and any expected requirement for
hydrophobic acrylic trifocal IOL.20 The TFNT00 model ocular secondary surgical interventions (SSIs; except neo-
has a nonsequential diffractive structure in the central dymium:yttriumealuminumegarnet capsulotomy) during the
study.
4.5-mm portion of the 6.0-mm biconvex central optical
zone, which is located on the aspheric anterior surface.21
The TFNT00 uses proprietary technology (ENLIGHTEN Study Procedures
optical technology) to redistribute light from the first Consented participants selected the IOL they preferred, which was
diffractive intermediate-order vision (120 cm) to the implanted sequentially into each eye after eligibility was
distance vision (refractive order).20 This creates an confirmed. Cataracts were removed using femtosecond laser-
enhanced distance add power to accompany the þ2.17- assisted cataract surgery techniques (LenSx; Alcon). The second
diopter (D) intermediate add power (60 cm; second dif- eye surgery was performed 7 to 30 days after the first.
fractive order) and þ3.25-D near add power (40 cm; third Postoperative visits were scheduled 1 to 2 days, 7 to 14 days, and
diffractive order) at the IOL plane,20e22 providing a range of 30 to 60 days after each eye’s surgery and 120 to 180 days after the
second eye surgery. Emmetropia was targeted in both eyes. A
vision from intermediate to near, while preserving distance
sponsor-provided electronic visual acuity system (Clinical Trial
vision. This novel diffractive structure has been shown to Suite; M&S Technologies, Inc, Niles, IL) was used for all study
provide high light use, transmitting 88% of light to the retina visual acuity and defocus testing. Uncorrected and corrected visual
at the simulated 3.0-mm pupil size,20 50% of which is acuity was measured at distance (4 m), intermediate (66 cm), and
allocated to distance vision, with 25% to intermediate near (40 cm). For defocus testing, patients were fitted with their
vision and 25% to near vision.20,23 The nonsequential best-corrected distance refraction, and visual acuity was measured
diffractive optics also have been shown to allow TFNT00 between þ1.50 D and e2.50 D in 0.5-D defocus steps, except in
to achieve a peak intermediate distance of 60 cm, which the region between þ0.50 D and e0.50 D, which was measured in
may benefit patients who need to perform tasks at arm’s 0.25-D steps. Binocular contrast sensitivity was assessed with the
length.21,24 Bench studies have verified this intermediate sponsor-provided CSV-1000HGT contrast sensitivity unit (Vector
Vision, Inc, Greenville, OH). Assessments under photopic
peak of 60 cm for the TFNT00.21 Clinical investigations
conditions were carried out at frequencies of 3, 6, 12, and 18 cycles
outside the United States have demonstrated a continuous per degree, with chart or screen background luminance of
range of vision from near to distance in TFNT00 approximately 85 cd/m2. Assessments under mesopic conditions
recipients24e26; however, available evidence of the perfor- were carried out both with and without glare at frequencies of 1.5,
mance of TFNT00 as compared with a monofocal IOL is 3, 6, and 12 cycles per degree. For mesopic conditions, participants
limited. The current study was conducted to evaluate the were fitted with neutral density filters to reduce their perception of
effectiveness and safety of the TFNT00 compared with a the chart luminance to approximately 3 cd/m2. Visual acuity
spherical monofocal IOL. measurements incorporated automated Early Treatment Diabetic
Retinopathy Study charts (M&S Technologies, Inc) using
algorithms in accordance with the American National Standards
Methods Institute (ANSI) Z80.21-2010 (R2015) and International Organi-
zation for Standardization standard 8596:2009. Patients were asked
Study Design proactively to rate their experience of visual disturbances subjec-
tively using the Questionnaire for Visual Disturbance (QUVID)
This was a United States Food and Drug Administrationeapproved, developed and validated by Alcon. The QUVID consists of picture-
prospective, multicenter, nonrandomized, parallel-group, assessor- referenced items that ask patients to report their experience of
masked, confirmatory trial to evaluate the effectiveness and safety of halos, glare, starbursts, hazy vision, blurred vision, double vision,
the TFNT00 when implanted in the capsular bag in the posterior and negative dysphotopsia (dark area) in terms of frequency,
chamber for the visual correction of aphakia in adult patients. severity, and bothersomeness. A 5-point response scale is provided
Patients in the control group were implanted with the single-piece from “never” to “always” for frequency, from “none” to “severe”
spherical monofocal SN60AT IOL (Alcon). Patients were not for severity of the patient’s worst experience, and from “not
charged for either the lens or implantation of the lens, regardless of bothered at all” to “bothered very much” for how much patients
their choice of lens for the study. The study was carried out between were bothered by the presence of specific photic phenomena. A
November 1, 2017, and September 27, 2018, and was conducted in rating of “bothered very much” is referred to as a “most bother-
accordance with the tenets of the Declaration of Helsinki, Interna- some” disturbance. The validated Intraocular Lens Satisfaction
tional Organization for Standardization standards 11979-7:2014 and (IOLSAT) questionnaire, developed by Alcon, was used to assess
14155:2011, and the Code of Federal Regulations. Institutional each participant’s satisfaction; need for spectacles overall and
review board approval was received for this study. Written informed at near, intermediate, and far distances; and quality of vision

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 Modi et al 
Diffractive Trifocal IOL Investigation

without spectacles. The QUVID and IOLSAT questionnaires were severity and bothersomeness of visual disturbances, and rates of
developed and recognized as validated based on guidance from the SSIs and AEs.
Food and Drug Administration.27

Effectiveness and Safety Outcomes Results

All primary and secondary outcomes were assessed at month 6. Patient Disposition and Demographics
The coprimary effectiveness outcomes were mean photopic
monocular BCDVA (4 m) and mean photopic monocular distance- A total of 250 participants were enrolled across 12 sites in the
corrected near visual acuity (DCNVA; 40 cm) for the first United States. Of these, 243 eligible patients (18e22 per site) were
operative eye. Secondary effectiveness outcomes included mean implanted successfully with the TFNT00 (n ¼ 129) or SN60AT
photopic monocular distance-corrected intermediate visual acuity (n ¼ 114) IOLs (Fig 1). Two participants in the TFNT00 group and
(DCIVA; 66 cm) for the first operative eye and the proportion of 3 in the SN60AT group were implanted unilaterally. Two TFNT00
participants who responded “never” to question 1 of the IOLSAT recipients discontinued participation after implantation of the study
questionnaire (regarding frequency of spectacle use in the past 7 IOLs and were considered lost to follow-up. One patient who was
days). The coprimary safety outcomes were the cumulative rate of implanted unilaterally with the SN60AT and subsequently
SSIs related to the optical properties of the IOL for the first underwent explantation was excluded from the all-implanted
operative eye and the mean binocular contrast sensitivity with and analysis set. Three patients in the SN60AT group were excluded
without glare for photopic and mesopic conditions. Other safety from the best-case analysis set because of macular degeneration
outcomes included the rate of severe and most bothersome visual and exclusion criteria. Patient demographics and baseline
disturbances and the cumulative rates of adverse events (AEs) in characteristics largely were similar between groups, although a
the first operative eye. higher proportion of SN60AT recipients were 65 years of age or
older compared with TFNT00 recipients (Table 1). Study
participants were primarily White, women, and of non-Hispanic/
Sample Size Calculation Latino ethnicity. Axial length, anterior chamber depth, corneal
The required sample size of 250 participants was planned for and lens thickness, photopic and mesopic pupil size, and absolute
bilateral implantation of study IOLs in a 1:1 ratio to ensure that at manifest refraction spherical equivalent also were similar between
least 226 eligible participants, 113 in each arm, completed the groups.
study to power the primary and secondary objectives at 83% or
more. This assumes a drop-out rate of 10%, a 0.1-logMAR Visual Outcomes
noninferiority margin, 0.0 expected difference, 0.18 standard
deviation, and 5% type I error for BCDVA; a 0.1-logMAR Monocular Distance-Corrected Visual Acuity. The coprimary
expected difference, 0.18 standard deviation, and 2.5% type I effectiveness outcomes were achieved for the first operative eyes at
error for DCNVA and DCIVA; and a 20% expected difference month 6 (Table 2). Noninferiority of the TFNT00 to the SN60AT
with a 2.5% type I error in spectacle independence. in mean BCDVA was established, based on a 95% UCL of 0.04
logMAR for the difference in least-squares means between the 2
Statistical Analysis groups, which was less than the 0.1-logMAR margin. The TFNT00
demonstrated superiority to the SN60AT in mean DCNVA based
The all-implanted analysis set (all eyes with successful implanta- on an estimated 97.5% UCL of less than 0.0 logMAR. A statisti-
tion plus at least 1 postoperative visit) was the primary analysis set cally significant difference of approximately 4 logMAR lines was
for all effectiveness end points, except the defocus curve. The observed in favor of the TFNT00 for DCNVA (P < 0.001).
safety analysis set (all eyes with attempted implantation) was the Secondary effectiveness outcomes for visual acuity also were
primary analysis set for all safety end points, except contrast achieved for the first operative eyes at month 6. The TFNT00
sensitivity. The best-case analysis set (all eyes successfully demonstrated superior mean photopic DCIVA compared with the
implanted with 1 postoperative visit, no preoperative ocular SN60AT based on an estimated 97.5% UCL of less than 0.0
pathologic features or macular degeneration, no major protocol logMAR. A statistically significant difference of at least 2.5
violations) was the primary analysis set for defocus curve and logMAR lines was observed in favor of the TFNT00 for DCIVA
contrast sensitivity. (P < 0.001). These results were supported by the demonstration of
Least-squares mean differences from a mixed-effects model noninferiority of the TFNT00 to the SN60AT in mean BCDVA
(fixed effect for treatment; random effect for site) with 95% and superiority of the TFNT00 to the SN60AT in mean DCNVA
(BCDVA) or 97.5% (DCNVA and DCIVA) upper confidence and DCIVA in the second operative eye at month 6.
intervals (CIs) were used to assess coprimary and secondary Binocular Distance-Corrected Visual Acuity. Binocular
effectiveness visual acuity end points. A 95% upper confidence distance-corrected visual acuity results for TFNT00 compared with
limit (UCL) of less than 0.1 logMAR was considered to support SN60AT demonstrated similar differences to those for monocular
noninferiority of the TFNT00 compared with the SN60AT for distance-corrected visual acuity (Table 3). Both the TFNT00 and
monocular photopic BCDVA, whereas a 97.5% UCL of less than SN60AT groups achieved a mean binocular BCDVA better than
0.0 logMAR supported superiority of the TFNT00 compared with 0.0 logMAR at month 6 (e0.062 logMAR [95% CI, e0.074 to
the SN60AT for monocular photopic DCNVA and DCIVA. An e0.051 logMAR] vs. e0.086 logMAR [95% CI, e0.098 to
estimated Mantel-Haenszel common difference in proportions of e0.074 logMAR], respectively). The observed difference in
patients with a “never” response (TFNT00 e SN60AT; site favor of the SN60AT compared with the TFNT00 for mean
included as a stratification variable) with 2-sided 95% CI was used binocular BCDVA was not clinically relevant (corresponding to
to assess the superiority of the TFNT00 compared with the 1 letter). The TFNT00 exhibited a clinically, significantly better
SN60AT for the secondary IOLSAT questionnaire effectiveness mean DCIVA compared with the SN60AT (<0.0 logMAR and
end point, with a 97.5% lower confidence limit of the common >0.2 logMAR, respectively) and a mean binocular DCNVA of
difference of more than 0% considered to support superiority. approximately 4 logMAR lines better than that of the SN60AT
Descriptive statistics were used to compare contrast sensitivity, (0.050 logMAR and 0.406 logMAR, respectively).

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Figure 1. Diagram showing patient flow. *Patients 2828.00005 and 5127.00022 were implanted unilaterally. yPatients 3828.00001 and 6097.00022 were
implanted unilaterally.

Table 1. Demographic Statistics and Baseline Characteristics (All-Implanted Analysis Set)

Characteristics TFNT00 (n [ 129) SN60AT (n [ 114) Overall (N [ 243)

Age (yrs)
<65, no. (%) 45 (34.9) 22 (19.3) 67 (27.6)
65, no. (%) 84 (65.1) 92 (80.7) 176 (72.4)
Mean (SD) 65.8 (7.31) 69.0 (6.46) 67.3 (7.09)
Female gender, no. (%) 85 (65.9) 79 (69.3) 164 (67.5)
Race, no. (%)
White 113 (87.6) 96 (84.2) 209 (86.0)
Black 8 (6.2) 11 (9.6) 19 (7.8)
Native American or Alaska Native 0 (0) 0 (0) 0 (0)
Asian 7 (5.4) 1 (0.9) 8 (3.3)
Native Hawaiian or other Pacific Islander 0 (0) 2 (1.8) 2 (0.8)
Other 1 (0.8) 4 (3.5) 5 (2.1)
Ethnicity, no. (%)
Hispanic or Latino 4 (3.1) 7 (6.1) 11 (4.5)
Not Hispanic or Latino 124 (96.1) 106 (93.0) 230 (94.7)
Not reported 1 (0.8) 1 (0.9) 2 (0.8)
Eye measurements (first eye), mean (SD)
Axial length (mm) 23.67 (0.94) 23.58 (0.87) 23.63 (0.91)
Mesopic pupil size (mm) 4.98 (1.07) 4.97 (1.04) 4.98 (1.06)
Photopic pupil size (mm) 4.14 (0.93) 4.10 (0.89) 4.12 (0.91)
Anterior chamber depth (mm) 3.27 (0.41) 3.24 (0.42) 3.26 (0.41)
Corneal thickness (mm) 548.11 (34.42) 549.92 (33.59) 548.96 (33.97)
Lens thickness (mm) 4.34 (0.51) 4.44 (0.48) 4.39 (0.50)
Absolute MRSE (D) 1.63 (1.56) 1.46 (1.21) 1.55 (1.40)

D ¼ diopter; MRSE ¼ manifest refraction spherical equivalent; SD ¼ standard deviation.

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Diffractive Trifocal IOL Investigation

Table 2. Primary Effectiveness End Points at 6 Months in the First Eye (All-Implanted Analysis Set)

Effectiveness End Point TFNT00 (n [ 127) SN60AT (n [ 113) TFNT00 e SN60AT

Monocular BCDVA (logMAR)*
Least-squares mean e0.014 e0.039 0.024
SE 0.0083 0.0087 0.0103
95% UCL 0.041
Monocular DCNVA (logMAR)y
Least-squares mean 0.105 0.529 e0.424
SE 0.0119 0.0127 0.0174
95% CI 0.081e0.128 0.504e0.554 e0.458 to e0.390
P value < 0.001
Monocular DCIVA (logMAR)y
Least-squares mean 0.070 0.327 e0.257
SE 0.0108 0.0114 0.0153
95% CI 0.048e0.092 0.304e0.350 e0.287 to e0.227
P value < 0.001

BCDVA ¼ best-corrected distance visual acuity; CI ¼ confidence interval; DCIVA ¼ distance-corrected intermediate visual acuity; DCNVA ¼ distance-
corrected near visual acuity; logMAR ¼ logarithm of the minimum angle of resolution; SE ¼ standard error; UCL ¼ upper confidence limit.
*Noninferiority hypothesis.
y
Superiority hypothesis.

Defocus Curve. Binocular defocus testing was consistent with Refractive Outcomes
the visual acuity results. The TFNT00 exhibited greater visual
acuity at the defocus range of e1.0 to e2.5 D (100e40 cm), with a At month 6, most first eyes in the TFNT00 (65.4%) and SN60AT
difference of 4 lines of logMAR visual acuity at e2.5 D (Fig 2). (60.2%) groups showed a manifest refraction spherical equivalent
The TFNT00 recipients maintained a mean visual acuity of 0.1 of þ0.25 D or less, and no eyes showed a manifest refraction
logMAR or less between the defocus range of þ0.5 and e2.5 D spherical equivalent of more than 1.0 D. Most first eyes in the
(200 and 40 cm). Both groups achieved a similar mean visual TFNT00 (84.3%) and SN60AT (83.2%) groups were within 0.5 D
acuity of 20/20 (0.03 logMAR) at the defocus range of þ0.5 to or less of the target refractive error at month 6. Results for the
e0.5 D. second eyes were similar to those for the first eyes.
Spectacle Independence. Based on the IOLSAT questionnaire,
a higher proportion of patients in the TFNT00 group compared Safety Outcomes
with the SN60AT group indicated never needing eyeglasses to see
overall (80.5% and 8.2%, respectively). The proportions of patients Adverse Events. The rates of SSIs in the first operative eye were
never requiring eyeglasses for distance were similar between the low for the TFNT00 (0.8%) and SN60AT (1.8%) groups (Table 4).
TFNT00 and SN60AT groups (95.9% and 84.5%, respectively). Each study group had 1 incident of IOL extraction for the first
However, more TFNT00 recipients compared with SN60AT operative eye. The TFNT00 explant was the result of subjective
recipients reported never requiring eyeglasses “up close” (83.6% reports of dissatisfaction with the level of vision, which were
and 8.2%, respectively) and “at arm’s length” (94.3% and 40.9%, determined to be related to the optical properties of the IOL. The
respectively). SN60AT explant was the result of posterior capsule rupture and
device dislocation (2.5-mm decentration, but no tilt, 2 days after
surgery) and was determined not to be related to the optical
Table 3. Supportive Effectiveness End Points: Binocular Distance- properties of the IOL. One SN60AT patient required intraocular
Corrected Visual Acuity at 6 Months (All-Implanted Analysis injections for age-related macular degeneration in the first opera-
Set) tive eye, although these SSIs also were deemed by the investigator
not to be related to the optical properties of the IOL. Similarly,
TFNT00 SN60AT none of the 3 SSIs reported in the second operative eyes (TFNT00,
Effectiveness End Point (n [ 127) (n [ 111) 1.6%; SN60AT, 0.9%) were considered related to the optical
properties of the IOL. In the TFNT00 group, these included
Binocular BCDVA (logMAR) vitreous prolapse and device dislocation (15 tilting, 120 days after
Mean (SD) e0.062 (0.066) e0.086 (0.063) surgery). In the SN60AT group, this included intraocular injections
95% CI e0.074 to e0.051 e0.098 to e0.074 for age-related macular degeneration. All other ocular AEs in both
Binocular DCIVA (logMAR) groups occurred at a rate of less than 5%, except for posterior
Mean (SD) e0.007 (0.079) 0.230 (0.124)
capsule opacification (13.2% in the TFNT00 first eyes and 15% in
95% CI e0.021 to 0.007 0.207e0.253
the TFNT00 second eyes) and increased intraocular pressure (5.4%
Binocular DCNVA (logMAR)
Mean (SD) 0.050 (0.070) 0.406 (0.148)
in the TFNT00 first eyes and 5.3% in the SN60AT first eyes). The
95% CI 0.038e0.062 0.378e0.434 rates of posterior capsulotomy in the TFNT00 and SN60AT groups
were 13.2% and 2.6% in the first operative eyes, respectively, and
11.8% and 3.6% in the second operative eyes, respectively. No
BCDVA ¼ best-corrected distance visual acuity; CI ¼ confidence interval; participants discontinued as a result of an AE and no deaths were
DCIVA ¼ distance-corrected intermediate visual acuity; DCNVA ¼ reported in the study.
distance-corrected near visual acuity; logMAR ¼ logarithm of the mini- Contrast Sensitivity. Mean binocular contrast sensitivity was
mum angle of resolution; SD ¼ standard deviation.
reduced for the TFNT00 compared with the SN60AT group at 6,

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 Ophthalmology Volume 128, Number 2, February 2021

Figure 2. Graph showing binocular defocus. D ¼ diopter; logMAR ¼ logarithm of the minimum angle of resolution.

12, and 18 cycles per degree in photopic conditions with or without 0.0%e4.9%], respectively). A higher proportion of SN60AT
glare and at 6 and 12 cycles per degree in mesopic conditions with recipients compared with TFNT00 recipients reported they were
or without glare (Fig 3). The maximum difference in means “not bothered at all” by starbursts, halos, and glare (79.8%,
observed between the 2 groups was 0.11 log units for any spatial 83.6%, and 69.4% vs. 55.2%, 51.2%, and 54.8%, respectively;
frequency. Fig 4).
Visual Disturbances. Visual disturbances of starbursts, halos, Patient Satisfaction. The proportion of recipients reporting
and glare were the most frequently rated severe symptoms in the being satisfied or very satisfied with their vision at month 6 was
TFNT00 and SN60AT groups. Starbursts, halos, and glare were similar between the TFNT00 and SN60AT groups (95.3% and
experienced at higher rates in the TFNT00 group compared with 90.9%, respectively). The numbers of recipients who reported
the SN60AT group at 1 and 6 months (Table 5). The incidence of being very satisfied were 74.0% and 60.0% in the TFNT00 and
severe starbursts increased from 1 to 6 months after surgery for SN60AT groups, respectively. In addition, 99.2% of patients said
TFNT00 recipients (11.4% [95% CI, 6.4%e18.4%] vs. 16.0% they would have the TFNT00 implanted again and 98.4% said they
[95% CI, 10.1%e23.6%], respectively) and SN60AT recipients would recommend the TFNT00 to their family or friends,
(0.9% [95% CI, 0.0%e5.0%] vs. 1.8% [95% CI, 0.2%e6.5%], compared with 87.4% and 95.5% of SN60AT recipients, respec-
respectively). The incidence of severe halos and glare tively. Among patients who experienced a severe visual distur-
experienced in the TFNT00 and SN60AT groups decreased from bance (TFNT00, n ¼ 31; SN60AT, n ¼ 3), 93.5% (n ¼ 29) of
1 to 6 months after surgery. Starbursts, halos, and glare also TFNT00 recipients were satisfied or very satisfied with their vision
were rated as the most bothersome symptoms by patients in the at month 6, compared with 33.3% (n ¼ 1) of SN60AT recipients.
TFNT00 group; 5% or less of TFNT00 and SN60AT recipients Furthermore, at month 6, 96.7% (n ¼ 30) of TFNT00 patients who
rated these symptoms as “bothered very much” (starbursts, 4.8% experienced a severe visual disturbance said they would have the
[95% CI, 1.8%e10.2%] and 0.9% [95% CI, 0.0%e5.0%]; halos, same lens implanted again and 93.5% (n ¼ 29) said they would
2.4% [95% CI, 0.5%e6.7%] and 0.9% [95% CI, 0.0%e5.0%]; recommend TFNT00 to their family or friends, compared with
and glare, 1.6% [95% CI, 0.2%e5.6%] and 0.9% [95% CI, 66.6% (n ¼ 2) of SN60AT recipients.

Table 4. Adverse Events in the First Eye (Safety Analysis Set)

TFNT00 (n [ 129) SN60AT (n [ 114) TFNT00 e SN60AT

95% Confidence 95% Confidence 95% Confidence
No. (%) Interval Event No. (%) Interval Event No. (%) Interval
Secondary surgical interventions
Any 1 (0.8) 0.02e4.24 d 2 (1.8) 0.21e6.19 d e1 (e1.0) e13.53 to 11.58
Related to optical properties 1 (0.8) 0.02e4.24 d 0 (0) 0e3.18 d 1 (0.8) e11.79 to 13.32
Not related to optical properties 0 (0) 0e2.82 d 1 (0.9) 0.02e4.79 d e1 (e0.9) e13.42 to 11.68
Not applicable to optical properties 0 (0) 0e2.82 d 1 (0.9) 0.02e4.79 d e1 (e0.9) e13.42 to 11.68
Ocular serious adverse events (including serious adverse device effects)
Lens extraction 1 (0.8) 0.02e4.24 1 1 (0.9) 0.02e4.79 1 d d
Intraocular injection 0 (0) 0e2.82 0 1 (0.9) 0.02e4.79 3 d d
Age-related macular degeneration 0 (0) 0e2.82 0 1 (0.9) 0.02e4.79 1 d d
Device dislocation 0 (0) 0e2.82 0 1 (0.9) 0.02e4.79 1 d d
Posterior capsule rupture 0 (0) 0e2.82 0 1 (0.9) 0.02e4.79 1 d d
Retinal tear 1 (0.8) 0.02e4.24 1 0 (0) 0.00e3.18 0 d d

d ¼ not reported.

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Figure 3. A, Graph showing mean binocular photopic contrast sensitivity without glare. B, Graph showing mean binocular photopic contrast sensitivity
with glare. C, Graph showing mean binocular mesopic contrast sensitivity without glare. D, Graph showing mean binocular mesopic contrast sensitivity with
glare.

Discussion TFNT00 was designed to target an intermediate focal

point of 60 cm, which is a distance associated
Diffractive trifocal IOLs provide an extended range of approximately with computer use.30e32
vision, from near to intermediate to distance.17e19 However, The present study evaluated the effectiveness of TFNT00
dividing incoming light into 3 foci may decrease the amount in providing a continuous range of vision in comparison
of energy directed to each of these points, which conse- with a spherical monofocal IOL, the SN60AT. In agreement
quently may affect visual acuity at all distances.28 Prior with previous studies,22,25 the TFNT00 exhibited a high
studies have highlighted this issue, reporting enhanced level of distance, intermediate, and near visual acuity. The
intermediate, but reduced near and distance, visual acuity, current study demonstrated that compared with a spherical
as well as optical qualities for trifocal IOLs compared monofocal IOL, the TFNT00 displayed comparable
with AcrySof IQ ReSTOR þ3.0-D28 and þ2.5-D bifocal monocular BCDVA and superior monocular DCNVA and
IOLs.29 DCIVA. Visual acuity results were supported by the
The TFNT00 is an IOL with 4 focal points and nonse- outcome of the defocus curves, where a clinically relevant
quential diffractive optics, which allow light redistribution difference in visual acuity in favor of the TFNT00 was
to create a functional trifocal with an enhanced distance observed at the defocus range of e1.0 to e2.5 D
power20 and þ2.17-D intermediate (60 cm) and þ3.25-D (100e40 cm). Patient-reported outcomes based on the
near (40 cm) add powers, with the aim of providing a validated IOLSAT questionnaire indicated that TFNT00
range of vision from intermediate to near, while preserving recipients were better able to engage in activities that
distance vision.21,22 Patient demand for functional required a range of vision while being spectacle free,
intermediate vision has grown with the increasing use of particularly at intermediate and near distances, compared
handheld devices and computers in daily life.22 The with SN60AT recipients.

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Table 5. Visual Disturbances at 1 and 6 Months (Safety Analysis Set)

TFNT00 (n [ 129) SN60AT (n [ 114) TFNT00 e SN60AT

No./Total (%) 95% Confidence Interval No./Total (%) 95% Confidence Interval % 95% Confidence Interval
1 mo
Patients with severe visual disturbance
Starbursts 14/123 (11.4) 6.4e18.4 1/110 (0.9) 0e5.0
Halos 28/127 (22.0) 15.2e30.3 1/109 (0.9) 0e5.0
Glare 6/125 (4.8) 1.8e10.2 3/110 (2.7) 0.6e7.8
Patients with a most bothersome visual disturbance
Starbursts 4/123 (3.3) 0.9e8.1 0/110 (0) 0e3.3
Halos 3/127 (2.4) 0.5e6.7 1/109 (0.9) 0e5.0
Glare 1/125 (0.8) 0.0e4.4 0/110 (0) 0e3.3
6 mos
Patients with severe visual disturbance
Starbursts 20/125 (16.0) 10.1e23.6 2/109 (1.8) 0.2e6.5 14.2 1.4e26.7
Halos 16/127 (12.6) 7.4e19.7 1/110 (0.9) 0e5.0 11.7 e1.1 to 24.2
Glare 4/126 (3.2) 0.9e7.9 2/111 (1.8) 0.2e6.4 1.4 e11.3 to 14.1
Patients with a most bothersome visual disturbance
Starbursts 6/125 (4.8) 1.8e10.2 1/109 (0.9) 0e5.0 3.9 e8.9 to 16.6
Halos 3/127 (2.4) 0.5e6.7 1/110 (0.9) 0e5.0 1.5 e11.3 to 14.2
Glare 2/126 (1.6) 0.2e5.6 1/111 (0.9) 0e4.9 0.7 e12.0 to 13.4

Both the TFNT00 and SN60AT groups demonstrated eyes occurred for the TFNT00 group. One patient in the
good patient satisfaction outcomes. More than 95% of TFNT00 group demonstrated tilt in the second eye, and
TFNT00 recipients were satisfied or very satisfied with their this was resolved by repositioning the IOL. The incidence
vision, as well as indicating that they would have the same of posterior capsulotomy was higher among TFNT00
lens implanted again and would recommend it to family or recipients than SN60AT recipients, which is in accordance
friends, compared with 87.4% or more of SN60AT with previous studies comparing AcrySof multifocal with
recipients for the same outcomes. AcrySof monofocal IOLs.33 However, the rates of
In line with previous studies,25 the TFNT00 exhibited an posterior capsulotomy among the TFNT00 group were
acceptable safety profile. No patients discontinued the study higher than those reported in previous studies of the same
as a result of an AE; one SSI related to the optical properties lens.34 It should be noted that the large majority (79.5%)
of the TFNT00 was reported, and neither group exceeded of posterior capsulotomies were performed at only 2 sites
the Food and Drug Administration grid rate for SSIs. No during the study. All but 1 patient who underwent
reports of IOL tilt or decentration in the first implanted posterior capsulotomy reported being satisfied or very
satisfied with their vision. All patients who underwent
posterior capsulotomy indicated they would have the same
lens implanted again.
Multifocal IOLs are commonly associated with reduced
contrast sensitivity.4,6,7,10,35e37 The splitting of light among
multiple focal points leads to a fraction of the light entering
the lens being used to produce an image at a given distance,
resulting in reduced contrast on the retinal image.35 Reduced
contrast sensitivity with multifocal IOLs has been described
at multiple6,8,36 spatial frequencies, with or without glare.4
The present study compared TFNT00 contrast sensitivity
with that of a spherical monofocal IOL, SN60AT, which
has been shown to be associated with good contrast
sensitivity outcomes.10 Contrast sensitivity outcomes were
analyzed in the best-case analysis set. The mean contrast
sensitivity was reduced slightly for TFNT00 recipients
compared with those who received the SN60AT at higher
spatial frequencies, regardless of photopic or mesopic con-
ditions or presence of glare. However, these observed dif-
ferences were less than levels of clinical significance.38
These results are in agreement with previous studies that
have demonstrated good contrast sensitivity outcomes in
Figure 4. Bar graphs showing level of bother experienced from a visual TFNT00 recipients.34,39,40 It is important to note that
disturbance at month 6 in (A) TFNT00 recipients and (B) SN60AT contrast sensitivity differences observed may have been
recipients. different if the comparator IOL had been an aspheric

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Diffractive Trifocal IOL Investigation

monofocal IOL. Reports have shown that spherical visual disturbances they experienced. However, a greater
monofocal IOLs41,42 have reduced contrast sensitivity number of patients in the SN60AT group compared with
compared with aspheric monofocal IOLs. the TFNT00 group were not bothered at all by visual
A common feature of multifocal5 and trifocal17e19,43,44 disturbances. Despite the higher occurrence of bother with
IOLs is the increased incidence of visual disturbances, visual disturbances, patient-reported satisfaction among
which consist of photic phenomena such as starbursts, TFNT00 recipients who experienced a severe visual distur-
halos, or glare.45 Recipients of diffractive trifocal IOLs bance were comparable with those of the entire TFNT00
have reported these photic phenomena.17e19,45 In the group, with 96.7% of implanted patients reporting that they
current study, visual disturbances were assessed using the would have the same lenses implanted again and 93.5%
QUVID questionnaire developed and validated by Alcon. saying they would recommend it to their family or friends.
Patients were asked proactively to rate the severity of the Limitations of the present study include non-
visual disturbances they experienced on a 5-point response randomization and how patients were unmasked to
scale from none to severe. The current study described the implanted IOLs. The fact that patients self-selected which
frequency of severe visual disturbances as a safety IOL they wished to receive had the potential to introduce
outcome.44e46 The TFNT00 recipients experienced severe bias, particularly for subjective results. The use of a
starbursts, halos, and glare, with more patients experiencing spherical monofocal IOL as the control rather than an
severe starbursts and halos in the TFNT00 group compared aspheric monofocal IOL in this study also can be considered
with the SN60AT group at months 1 and 6. A reduction in a limitation, because the latter is associated with superior
TFNT00 recipients experiencing severe halos and glare contrast sensitivity outcomes.41,42
between months 1 and 6 was observed, as is expected over In summary, this study demonstrated that when
time.44,45,47 compared with a spherical monofocal IOL (SN60AT), the
Visual disturbances are a common source of patient TFNT00 trifocal IOL provides a continuous range of vision
dissatisfaction with,48 and are a reason for explantation of, from distance to near, with increased spectacle indepen-
multifocal IOLs.49 Therefore, when determining the dence. Despite a comparative decline in contrast sensitivity
prevalence of visual disturbances, it is also important to and increased visual disturbances, patient satisfaction
assess the patients’ perspective regarding how much they remained high for the TFNT00 trifocal IOL.
are bothered by the presence of such photic phenomena.
Using the QUVID questionnaire, patients rated the level of Acknowledgment
bother experienced by visual disturbances, ranging from
“not bothered at all” to “bothered very much,” the latter The authors thank Joseph Wright for editorial assistance in
being considered as “most bothersome.” Less than 5% of the preparation of the manuscript, with funding from Alcon
TFNT00 recipients rated being bothered very much by the Research LLC.

Footnotes and Disclosures

Originally received: March 27, 2020. V.T.: Consultant and personal fees e Alcon
Final revision: July 2, 2020. B.F.: Consultant and grant support e Alcon
Accepted: July 7, 2020. J.G.H.: Grant, personal fees, and nonfinancial support e Alcon
Available online: September 28, 2020. Manuscript no. D-20-00516
1
E.Y.: Consultant e Alcon
Seeta Eye Centers, Poughkeepsie, New York.
Sponsored by Alcon Research LLC, Fort Worth, Texas. The sponsor
2
Lehmann Eye Center, Nacogdoches, Texas. participated in the design of the study; data management; data analysis;
3
California Eye Institute, Fresno, California. interpretation of the data; and preparation, review, and approval of the
4
Carolina Eyecare Physicians, LLC, Mount Pleasant, South Carolina. manuscript.
5 HUMAN SUBJECTS: Human subjects were included in this study. The
The Eye Institute of Utah, Salt Lake City, Utah.
6
study was conducted in accordance with the tenets of the Declaration of
Vance Thompson Vision, Sioux Falls, South Dakota. Helsinki, International Organization for Standardization standards 11979-
7
Vision For Life, Nashville, Tennessee. 7:2014 and 14155:2011, and the Code of Federal Regulations. Institutional
8
Berkeley Eye Center, Houston, Texas. review board approval was received for this study. The Sterling Institutional
9 Review Board (Atlanta, Georgia) was used for all 12 investigative sites.
Eye Center of North Florida, Panama City, Florida.
Written informed consent was obtained from all patients.
10
Texas Eye and Laser Center, Hurst, Texas. No animal subjects were included in this study.
11
Virginia Eye Consultants, Norfolk, Virginia. Author Contributions:
Disclosure(s): Conception and design: Modi
All authors have completed and submitted the ICMJE disclosures form.
Analysis and interpretation: N/A
The author(s) have made the following disclosure(s): A.M.: Consultant and
Data collection: Modi, Lehmann, Maxwell, Solomon, Cionni, Thompson,
personal fees e Alcon
Horn, Caplan, Fisher, Hu, Yeu
K.S.: Consultant, grant, and personal fees e Alcon
Obtained funding: Maxwell, Solomon, Cionni, Thompson, Fisher, Hu, Yeu;
R.C.: Consultant e Alcon Study was performed as part of the authors' regular employment duties.
J.H.: Consultant and personal fees e Alcon

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 Ophthalmology Volume 128, Number 2, February 2021
Overall responsibility: Modi, Lehmann, Maxwell, Solomon, Cionni, Key Words:
Thompson, Horn, Caplan, Fisher, Hu, Yeu binocular vision, cataract, contrast sensitivity, diffractive, monofocal intraoc-
Abbreviations and Acronyms: ular lenses, monocular vision, multifocal intraocular lenses, nonapodized,
AE ¼ adverse event; BCDVA ¼ best-corrected distance visual acuity; spectacle dependence, trifocal intraocular lenses, visual acuity.
CI ¼ confidence interval; D ¼ diopter; DCIVA ¼ distance-corrected in- Correspondence:
termediate visual acuity; DCNVA ¼ distance-corrected near visual acuity; Satish Modi, MD, FRCS(C), Seeta Eye Centers, 23 Davis Avenue,
IOL ¼ intraocular lens; IOLSAT ¼ Intraocular Lens Satisfaction; Poughkeepsie, NY 12603. E-mail: smodieyes@aol.com.
logMAR ¼ logarithm of the minimum angle of resolution;
QUVID ¼ Questionnaire for Visual Disturbance; SSI ¼ secondary surgical
intervention; UCL ¼ upper confidence limit.

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