Efficacy of Photorefractive Keratectomy

for Military Pilot Recruitment in an

Asian Air Force

Brian See, Gerard Nah, Wee Hoe Gan, Robin Low

AsMA Annual Scientific Meeting 2013

Chicago, IL, USA
 Disclosure Information
84th AsMA Annual Scientific Meeting – MAJ (Dr) Brian See

I have the following financial relationships to disclose:

– Employee of: Republic of Singapore Air Force (RSAF)

I will not discuss off-label use and/or investigational use in

my presentation.
Disclaimer:
– The opinions and recommendations expressed in this
presentation remain that of the authors’ and may not reflect
the official policy or position of the RSAF Medical Service,
the RSAF, or the Ministry of Defence, Singapore.
 Scope of Presentation

• Introduction
• Study details
– Objectives
– Design, subjects and methods
– Results
• Discussion
• Introduction
• Study details
– Objectives
– Design, subjects and methods
– Results
• Discussion
 Myopia in Singapore
• Age-adjusted prevalence among adults
– Chinese: 38.7%1
– Malay: 26.2%2
– Indian: 28.0%3
• Increase in prevalence among SAF conscripts
– 1987-19924 to 1996-19975: 19.9%
– 1996-19975 to 2009-20106: 2.3%

1. Wong TY, et al. Invest Ophthalmol Vis Sci. 2000;41:2486-94.

2. Saw SM, et al. Ophthalmology. 2008;115:1713-9.
3. Pan CW, et al. Invest Ophthalmol Vis Sci. 2011;52:3166-73.
4. Au Eong KG, et al. Singapore Med J. 1993;34:29-32.
5. Wu HM, et al. Report on study of myopia and its impact in a cohort of SAF enlistees. Singapore: DMRI; 1998.
6. Saw SM, et al. Association for Research in Vision and Ophthalmology 2011 Annual Meeting, 1-5 May 2011; Fort Lauderdale, FL.
 RSAF CRS Program

• Implemented in end-2005 to enlarge the

recruitment pool of potential military aviators
• Choice of CRS modality was PRK
– Concerns over stability of LASIK corneal flap and risk
of traumatic flap dislocation
• Several case reports documented minor trauma causing late
dislocation of flap1-5
• Histological studies in rabbits show that flap heals by
epithelial adhesion at circumferential edge of wound only6-7

1. Sridhar MS, et al. Am J Ophthalmol. 2001;132:780-2. 5. Melki SA, et al. Ophthalmology. 2000;107:2136-9.
2. Patel CK, et al. Arch Ophthalmol. 2001;119:447-9. 6. Kato K, et al. Br J Ophthalmol. 1999;83:1302-5.
3. Iskandar NG et al. J Cataract Refract Surg. 2001;27:1111-4. 7. Wachtlin J, et al. J Refract Surg. 1999;15:451-8.
4. Leung ATS, et al. J Cataract Refrat Surg. 2000;26:135-9.
 PRK: RSAF Selection Criteria
• Medical selection criteria for enrollment
– Not worse than -5.00D spherical error
– Not worse than -2.00D cylindrical error
• Rationale
– High myopia (SE worse than -6 D) associated with
increased risk of other ocular pathologies1
• Cataracts
• Glaucoma
• Retinal detachment

1. Saw SM, et al. Ophthal Physiol Opt. 2005;25:381-91.

• Introduction
• Study details
– Objectives
– Design, subjects and methods
– Results
• Discussion
 Objectives

• To determine the efficacy and safety of

Photorefractive Keratectomy (PRK) in young
patients with low-moderate myopia (SE better than -6D)
• To review the efficacy and safety of the RSAF
Corneal Refractive Surgery (CRS) Program
 Design and Subjects

• Design
– Retrospective, consecutive case series
– Single-centre, multi-surgeon
– Study period: 5 years (1 Jan 06 – 31 Dec 10)
• Subjects
– 149 eyes of 76 consecutive patients who underwent
PRK as part of the RSAF CRS Program during the
study period
• 3 patients underwent unilateral PRK
 Methods

• The following were mined from paper-based

medical records of all subjects and analysed:
– Pre- and post-operative refraction, UDVA and CDVA
– Post-operative corneal haze grading and retreatments
• For each outcome measure, the following were
excluded from analysis:
– Eyes that underwent retreatment at any point during
the study period (except for cumulative incidences)
– Eyes that had incomplete records for the outcome
measure
 Subject Characteristics

• Age
– Median: 21 years (range, 18 – 26 years)
– Mean: 20.9 ± 1.8 years
• Sex
– Male: 73 (96.1%)
– Female: 3 (3.9%)
• Pre-op SE refraction
– Mean: -3.39D ± 1.19D
– Range: -6.25D to +0.28D
 Outcome Measures

• Efficacy
– Post-operative uncorrected distant visual acuity (UDVA)
– Spherical equivalent (SE) refractive accuracy
• SE refraction was derived from the algebraic sum of the
spherical error and half of the cylindrical error
• Safety
– Change in corrected distant visual acuity (CDVA)
– Retreatment rates
• Others
– Stability of SE refraction
 Efficacy: Post-operative UDVA
133 Eyes Cumulative UDVA (LogMAR) 20/20 or better:
12 months post-op 98.5%
98.5% 98.5% 100% 98.5% 100% 100%

82.7%
73.7%
% of Eyes

36.8%

27.8%
 Efficacy: SE Refractive Accuracy
137 Eyes
12 months post-op ±0.50D: 100%

81.8%
% of Eyes

10.2% 8.0%
 Safety: Change in CDVA
128 Eyes Loss of
12 months post-op ≥ 2 lines: 2.3%

64.1%
% of Eyes

21.9%

9.4%
2.3% 2.3%
 Safety: Retreatment Rates

• Retreatments: 10 eyes (cumulative incidence, 6.7%)

– ≥ Grade 2 haze: 9 eyes (6.0%)
– Unsatisfactory refraction: 1 eye (0.7%)
 Stability: 6 to 12 Months Post-op
% changed > 0.50D
34 Eyes Stability of SE Refraction 6-12 mo: 0%
Mean SE Refraction (D)

+0.13

-3.75

Time after Surgery (Months)

 Stability: 4 to 12 Months Post-op
% changed > 0.50D
94 Eyes Stability of SE Refraction 4-12 mo: 0%
Mean SE Refraction (D)

-0.06

-3.21

Time after Surgery (Months)

• Introduction
• Study details
– Objectives
– Design, subjects and methods
– Results
• Discussion
 Discussion: Efficacy
Outcome Measure
RSAF CRS Program Murray, et al1
(at ≥ 12 months)
70.4% (range, 0.4% – 87.0%)
Post-op UDVA
98.5% Low-moderate: 76.4%
20/20 or better
(range, 50.7% – 82.0%)

92.3% (range, 37.6% – 98.8%)

Post-op UDVA
100.0% Low-moderate: 96.3%
20/40 or better
(range, 78.2% – 97.0%)

68.0% (range, 56.5% – 87.4%)

SE within ±0.50D of
100.0% Low-moderate: 86.6%
intended correction
(range, 39.1% – 95.8%)

71.6% (range, 65.0% – 88.7%)

SE within ±1.00D of
100.0% Low-moderate: 90.4%
intended correction
(range, 78.3% – 98.8%)
1. Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
 Discussion: Safety

Outcome Measure
RSAF CRS Program Murray, et al1
(at last follow-up)
0.5% (range, 0% – 20.5%)
CDVA ≥ 2 lines lost 2.3% Low-moderate: 0.5%
(range, 0% – 1.1%)

4.5% (range, 0.7% – 15.3%)

CDVA ≥ 1 line lost 11.7%
Low-moderate: 14.9%
Clinically significant Cumulative incidence,
Cumulative incidence, 6.0%
corneal haze 2% – 4%2

1. Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
2. Parekh P, Davis EA. Prevention and treatment of haze in refractive surgery. Int Ophthalmol Clin 2008;48:29-40.
 Discussion: Stability of Refraction

• Post-op grounding period of military aviators

shortened from 6 to 4 months in 2008
– Study shows that there was no increase in % change
in SE > 0.50 D from 6 – 12 months to 4 – 12 months
– Possibility of further shortening of grounding period
• Supported by other studies1

Outcome 6 – 12 Months 4 – 12 Months 3 – 12 Months 1 – 12 Months

Measure (N=34) (N=94) (N=94) (N=94)
% Change in
0% 0% 0% 4.3%
SE > 0.50D

1. Hersh PS, et al. Ophthalmology 1998;105:1512-23. (N=105, prospective case series)

 Discussion: Limitations

• Case series design

– Prone to bias (especially selection)
• Use of medical records retrospectively
– Variable quality of clinical entries / incomplete
records
• Last follow-up at post-op month 12
– Unable to determine long-term efficacy and safety
 Questions?

Thank you!

Contact author:
MAJ (Dr) Brian See
Head, Performance Maximisation Branch
Aeromedical Centre, Republic of Singapore Air Force
e-mail: see_cheong_yan_brian@starnet.gov.sg
 LogMAR

• LogMAR: Logarithm of
the Minumium Angle of
Resolution
– Advantages over Snellen
chart
• Equal no of letter per line
• Regular progression
• Final score based precisely
on total of all letters read
– Recommended for
research
Grosvenor T. Primary care optometry. 5th ed. St Louis: Elsevier; 2006.
 Corneal Refractive Surgery (CRS)

• PRK
– Cornea epithelium removed with dilute alcohol
– Anterior corneal surface reshaped by excimer laser
– Re-epithelialisation generally occurs within 3-4 day
– Complications:
• Subjective symptoms
• Refractive complications
• Corneal haze
• Microbial keratitis (rare)

Source:
http://www.freeholdeye.com/images/lasik-
surgery-brick-nj.jpg
 Corneal Refractive Surgery (CRS)

• LASIK
– Corneal flap created using microkeratome
– Underlying corneal stroma reshaped by excimer laser
– Corneal flap replaced over stroma, no sutures required
– Complications:
• Subjective symptoms
• Refractive complications
• Corneal haze and oedema
• Flap-related complications (rare)
• Microbial keratitis (rare)
Source:
http://www.freeholdeye.com/images/lasik-
surgery-freehold-nj.jpg
 Murray, et al; 2005

• Systematic review of 30 case

series reports on PRK that met
inclusion criteria:
– Published from year 2000 onwards
– Prospective studies: > 50 eyes,
Retrospective studies: > 100 eyes
– Assessed to be of good quality
using 14-question questionnaire

Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
 Murray, et al; 2005: Efficacy

UDVA at ≥ 12 months
• 6/6 or better
– Overall: 70.4% (range, 0.4% – 87.0%) [10 studies]
– Low-moderate myopia: 76.4% (range, 50.7% – 82.0%) [3 studies]
• 6/12 or better
– Overall: 92.3% (range, 37.6% – 98.8%) [9 studies]
– Low-moderate myopia: 96.3% (range, 78.2% – 97.0%) [3 studies]

Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
 Murray, et al; 2005: Efficacy

Accuracy at ≥ 12 months
• SE within 0.50D of intended correction
– Overall: 68.0% (range, 56.5% – 87.4%) [13 studies]
– Low-moderate myopia: 86.6% (range, 39.1% – 95.8%) [4 studies]
• SE within 1.00D of intended correction
– Overall: 71.6% (range, 65.0% – 88.7%) [13 studies]
– Low-moderate myopia: 90.4% (range, 78.3% – 98.8%) [4 studies]

Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
 Murray, et al; 2005: Safety

• Refractive complications at last follow-up

– Loss of 1 line CDVA
• Overall: 4.5% (range, 0.7% – 15.3%) [13 studies]
• Low-moderate myopes: 14.9%1 [1 study]
– Loss of ≥ 2 lines CDVA
• Overall: 0.5% (range, 0% – 20.5%) [13 studies]
• Low-moderate myopes: 0.5% (range, 0% – 1.1%)1-2 [3 studies]
• Corneal haze
– Grade ≥ 2 at last follow-up: 0% (range, 0% – 16.3%) [8 studies]
Murray A, et al. A systematic review of the safety and efficacy of elective photorefractive surgery for the correction of
refractive error. 2005.
1. Kapadia MS, Wilson SE. Cornea 2000;19:180-4.
2. Nagy ZZ, et al. J Refract Surg 2001;17:319-26.
 Standard Graphs for CRS Results

Dupps WJ Jr, et al. J Cataract Refract Surg 2011;37:1-3.

Waring GO 3rd, et al. J Refract Surg 2011;27:7-9.
Stulting RD, et al. Cornea 2011;30:945-7.