Excimer Laser for Hyperopia: Wider Limits

Excimer Laser for Hyperopia: Wider Limits Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4  ’  ’

Financial Disclosure Consultant Carl Zeiss Meditec Patents VHF digital ultrasound technology Small equity holder Arcscan Inc. Colorado, USA (Artemis 3)

MEL80 High Hyperopia Outcomes 222 Eyes 158 Patients Hyperopia [+4.00 to +7.00 D], mean +5.18 ± 0.88 D Cylinder [0.00 to -3.00 D], mean -0.97 ± 0.66 D Age [18 to 78 years], median 49 years BSCVA 79% 20/20 Enhancement rate 19% This includes enhancements for patient who could see 20/20 If enhancement had been denied for 20/25 or better, the enhancement rate would have been 8% Planned two-stage treatments = 22% (none enhanced)

MEL80 High Hyperopia: Monocular Efficacy

MEL80 High Hyperopia: Accuracy Within ±0.50 D 65% Within ±1.00 D 93%

MEL80 High Hyperopia: Accuracy

MEL80 High Hyperopia: Safety – BSCVA

Retinal Image magnification in hyperopia Decreased retinal image size will result in a decrease in BSCVA Refraction Vertex distance Change in retinal image size Ratio retinal image size glasses/Rx surgery Theoretical VA after corneal Rx surgery +4.00 D 12 mm -4.8% 0.95 20/21 +4.00 D 16 mm -6.4% 0.94 20/21 +7.00 D 12 mm -8.4% 0.92 20/22 +7.00 D 16 mm -11.2% 0.89 20/23

MEL80 High Hyperopia: Contrast Sensitivity * * * * * Statistically significant (p<0.05)

Stability Four-year postoperative results of the US ALLEGRETTO WAVE for the treatment of hyperopia – Kezirian et al – JRS. 2008; 24: S431-438 Hyperopia from +0.375D to +6.125D Mean change = +0.19 ± 0.53D 66.7% of eyes were stable within ± 0.50D Change in mean keratometry Change in refraction Mean change = +0.03 ± 0.78D 75.% of eyes were stable within ± 0.50D

Hyperopic Ablation Profiles 1 st Generation Asclepion Meditec MEL60 – 1 st Nidek EC5000 Summit Apex Plus (Axicon Masks) VISX S2 Schwind Keratom (fractile mask) 2 nd Generation Technolas 117C (B&L 217C) (2-mm spot tophat) MEL70 – advanced transition zone (1.8-mm gaussian spot)

Hyperopic Ablation Profiles (cont) 3 rd Generation Wavelight Allegretto Schwind ESIRIS/Amaris MEL80 (Carl Zeiss Meditec) [ Wavefront Guided Hyperopia - ??????? ]

1 st Generation Hyperopic Profile – 1997 +4.00 D primary PRK Nidek EC5000 88% regression after 6 months +3.50 D enhancement Corneal perforation during the enhancement Immediate corneal transplant required Phaco/PCIOL - > UCVA 20/32

1 st Generation Hyperopic Profile – 1997 35 year old F +3.00 D primary LASIK with the Nidek EC5000 95% regression after 6 months Unknown cause Artemis VHF digital ultrasound scans showed epithelial reversal of ablation contour

Early Hyperopic Treatment – 1999

Scans demonstrate the inadequacies of the ablation profile design Short transition zone used 1st Generation Hyperopic Profile – 1997

2 nd Generation Hyperopic Profile - 2007 +4.00 D primary LASIK with the B&L 217z Optical zone used: 6-mm Optical zone by epithelium & topography: 5-mm Artemis Epithelium Orbscan Topography 5-mm

MEL80 Topography Guided Retreatment MEL80 topography guided ablation for hyperopic zone enlargement & recentration Post-op optical zone by epithelium: 7-mm Artemis Epithelium Pre Post Change 7-mm

Improvements in technique of hyperopic LASIK

Ablation Profile Design Improvements Smaller OZ Poor stability Small optical zones VISX S2 5.5mm VISX S2 5.5mm B&L 217c 6mm

3 rd Generation Ablation Profile Design Good stability (2 years) Large optical zones Schwind Wavelight MEL80 Pre Post Change MEL80 +5.50 ablation

Epithelial Changes in Newer Ablation Profiles Ultrasound Study (Reinstein et al. unpublished data) Average post-op epithelial thickness profile for 71 eyes Hyperopic treatments in a 7 mm zone with the MEL80 Attempted hyperopia: +4.69 ± 1.91 [+1.00, +7.00] Average optical zone by epithelial changes: 7 mm Artemis Epithelium

Awareness of “Apical Syndrome” Excess hyperopic steepening can lead to epithelial breakdown This limits the amount of hyperopic correction depending on how steep the cornea is to start with MEL80 - approx 0.75 D of steepening (mean sim K’s) for each 1.00 D hyperopia treated Most surgeons use a limit of about 49 D (estimated postop simK)

Epithelial Thinning in Hyperopic Ablation (Reinstein et al. unpublished data) A more accurate method of determining how much hyperopic treatment can be performed is to actually measure the epithelial thickness Central epithelial thinning ~ attempted correction Peripheral epithelial thickening ~ attempted correction

Post op maximum K can be misleading Patient could have a flat cornea, but thin epithelium Not suitable for further treatment Patient could have a steep cornea, but thick epithelium Suitable for further treatment Epithelial Thinning in Hyperopic Ablation (Reinstein et al. unpublished data)

Apical Syndrome Rate of change of curvature affects epithelial breakdown Higher if a smaller zone Higher if a larger correction

Apical Syndrome: Treated by Trans-Epi PTK Artemis guided trans-epithelial PTK AGTEPTK Simulation Pre 3 mo 6 wks 1 day Epithelium & Scar Depth

Techniques: Two-stage treatment Artemis two-stage treatment for refractions over +5.50D Primary treatment: up to +5.50D in the maximum hyperopic meridian 2. Post-operative Artemis 3. Peripheral residual stromal thickness (Artemis) Measurement of thinnest epithelium Calculation of treatable remaining hyperopia based on vertex epithelial thickness

Centration on the Corneal Vertex (approximates the visual axis)

Centration of Hyperopic Correction We choose to centre all treatments on the visual axis Phoroptor Lens No Angle Kappa Large Angle Kappa Phoroptor Lens

Centration of Hyperopic Correction We choose to centre all treatments on the visual axis Centre on the visual axis Centre on the pupil Ablation Ablation

Flap Centration Flap centration in high hyperopia with large nasal angle kappa Orbscan Eye Image Hansatome Flap Hansatome Ring/Flap OD OS

Centration of Ablation Example: High hyperope with large nasal angle kappa Orbscan Eye Image MEL80 Eye Tracker Images rotated 180  as taken from surgeon’s microscope view

Centration of Hyperopic Ablation Example: High hyperope with large nasal angle kappa Ablation well centered on topography MEL80 Centration Hyperopia: 0.07 ± 0.07 mm (unpublished data)

Wavefront correction for Hyperopia? Ocular wavefront is measured with the pupil centre as the reference (OSA convention!) Hyperopic ablation and flap creation should be centred on the visual axis Pupil centre ( ) and the visual axis ( ) ARE NOT coincident: 85% of hyperopes have a positive angle kappa Patients with large kappa will have large coma (relative to pupil centre=OSA) HOWEVER they do not have symptoms of coma ! Wavefront guided treatment would move the corneal vertex to a new position by flattening the “so-called” coma (relative to pupil centre) – this would certainly induce symptoms of coma!

Example: Hyperopic Postop - OD Patient’s subjective symptoms OD Wavefront (Pupil Centre ) Visual Symptoms do NOT match PSF by wavefront ( pupil centre)

Example: Hyperopic Postop - OD Patient’s subjective symptoms OD Wavefront (Corneal Vertex) Visual Symptoms DO match PSF by wavefront ( corneal vertex)

Pearls for High Hyperopic LASIK 3 rd Generation Laser Platforms achieve large optical zone & better transition zones Visual outcomes are good – efficacy, safety, stability 2-stage treatment where appropriate to optimise safety Centration on the corneal vertex Topography guided treatment available for optical zone enlargement & recentration Epithelial thickness profiles to monitor epithelial breakdown and avoid apical syndrome Alternative: IOLs?

LASIK or IOLs? Equal or better outcomes Equal or better safety No risk of rare, but catastrophic intra-ocular complications Standard LASIK safety Ease of attaining exact target refraction (enhancement) Patient preference Simultaneously provides good visual function at distance and near

Excimer Laser for Hyperopia: What Are Age and Degree Limits? Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4  ’  ’ Thank You

Why is corneal treatment best? Improvements in technique of hyperopic LASIK Equal or better outcomes Equal or better safety No risk of rare, but catastrophic intra-ocular complications Low risk of other complications Ease of attaining exact target refraction (enhancement) Patient preference Simultaneously provides good visual function at distance and near

Outcomes: Efficacy Desai et al - Long-term results of the Artisan IOL for the correction of severe and extreme hyperopia in the United States: A prospective Multi-Center Study – ARVO 2008. Pop M. Payette Y. Refractive lens exchange versus iris-claw Artisan Phakic Intraocular Lens for Hyperopia. J Refract Surg. 2004;20:20-24 Davidorf et al – Posterior chamber phakic intraocular lens for hyperopia +4 to +11 diopters. J Refract Surg. 1998; 14(3): 306-311 Gil-Cazorla – Phakic Refractive Lens (Medennium) for correction of +4.00 to +6.00 Diopters: 1-year follow-up. J Refract Surg. 2008;24:350-4 Dick et al – Refractive lens exchange with an array mutifocal IOL – J Refract Surg. 2002;18:509-518 Efficacy: UCVA Rx treated ≥ 20/20 ≥ 20/40 Artisan IOL FDA study [1] +4.00 to +12.00D 21.4% 85.5% Artisan phakic IOL [2] +2.75 to +9.25 D 67% ≥ 20/25 89% Staar ICL [3] +4.00 to +11.00D 8% 63% PRL (Carl Zeiss Meditec) [4] +4.00 to +6.00D 12.5% 100% RLE & multifocal IOL [5] +1.75 to +6.00D 31% 100% LASIK – MEL80 +4.00 to +7.00 D 71% 100%

Outcomes: Accuracy Phakic IOLs Desai et al - Long-term results of the Artisan IOL for the correction of severe and extreme hyperopia in the United States: A prospective Multi-Center Study – ARVO 2008. Pop M. Payette Y. Refractive lens exchange versus iris-claw Artisan Phakic Intraocular Lens for Hyperopia. J Refract Surg. 2004;20:20-24 Sanexa et al –Three-year follow-up of the Artisan phakic intraocular lens for hypermetropia. Ophthalmology. 2003; 110(7): 1391-5 Davidorf et al – Posterior chamber phakic intraocular lens for hyperopia +4 to +11 diopters. J Refract Surg. 1998; 14(3): 306-311 Accuracy within Rx treated ± 0.50D ± 1.00 D Artisan IOL FDA study [1] +4.00 to +12.00D 65.5% 98.2% Artisan phakic IOL [2] +2.75 to +9.25 D 50% 78% Artisan phakic IOL [3] +3.00 to +11.00D NA 81.8% Posterior chamber phakic IOL [4] +4.00 to +11.00D 58% 79% LASIK – MEL80 +4.00 to +7.00 D 65% 93%

Outcomes: Accuracy RLE (PCIOLs) 2. Pop M. Payette Y. Refractive lens exchange versus iris-claw Artisan Phakic Intraocular Lens for Hyperopia. J Refract Surg. 2004;20:20-24 Dick et al – Refractive lens exchange with an array mutifocal IOL – J Refract Surg. 2002;18:509-518 Preetha et al – Clear lens extraction with intraocular lens implantation for hyperopia. J Cataract Refract Surg. 2003;29: 895-899 Accuracy within Rx treated ± 0.50D ± 1.00 D RLE & multifocal IOL [5] +1.75 to +6.00D 88% 100% RLE Staar/Rayner IOL [6] +4.75 to +13.00 D 70% 90% Acrysoft RLE [2] +2.75 to +7.50 D 55% 91% LASIK – MEL80 +4.00 to +7.00 D 65% 93%

Outcomes: Contrast Sensitivity – Intraocular Tx Below normal contrast sensitivity for both ReSTOR lens types

Safety: loss of lines Gil-Cazorla R. Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 Diopters: 1-year follow-up. J Refract Surg. 2008;24:350-354 Preetha et al – Clear lens extraction with intraocular lens implantation for hyperopia. J Cataract Refract Surg. 2003;29: 895-899 Dick et al – Refractive lens exchange with an array mutifocal IOL – J Refract Surg. 2002;18:509-518 Pop M. Payette Y. Refractive lens exchange versus iris-claw Artisan Phakic Intraocular Lens for Hyperopia. J Refract Surg. 2004;20:20-24 Davidorf et al – Posterior chamber phakic intraocular lens for hyperopia +4 to +11 diopters. J Refract Surg. 1998; 14(3): 306-311 Munoz et al – Artisan iris-claw phakic intraocular lens followed by LASIK for hyperopia. J Refract Surg. 2005;31:308-317. Lose 2 lines Lose 1 line PRL Medennium [1] 0 31.25 Staar or Rayner CLE [2] 0 10 Array CLE [3] 0 12 Artisan [4] 0 0 Acrysof CLE [4] 0 0 PRL [5] 4 NA Artisan [6] 0.1 38.4 MEL80 LASIK 0 23

Catastrophic complications Endophtalmitis Cystoid Macular Edema Retinal detachment Corneal decompensation/transplant

Catastrophic complications Endophthalmitis Risk for cataract surgery: 1/1000 to 1/10000 [Lundstrom M. et al ] 1. Lundstrom M. Endophthalmitis after cataract surgery: a nationwide prospective study evaluating incidence in relation to incision type and location. Ophthalmology. 2007; 114: 870-886.

Catastrophic complications Cystoid Macular Edema Risk after cataract surgery: 1% to 6% [1,2] after uncomplicated phakic surgery 1. Ray S, D’Amico DJ. Pseudophakic cystoid macular edema. Semin Ophthalmol. 2002;17:167-180. 2. Powe NR, Schein OD, Gieser SC, et al. Synthesis of the literature on visual acuity and complications following cataract extraction with intraocular lens implantation. Arch Ophthalmol. 1994;112:239-252.

Catastrophic complications Retinal Detachment Risk after cataract surgery: 0.41% [1] 0.25% [2] 2.87% [3] (high myopia) 1. Boberg-Ans et al. Retinal detachment after phacoemulsification cataract extraction. J Cataract Refract Surg. 2003 Jul;29(7):1333-8. . 2, Guell et al – Five-year follow-up of 399 phakic Artisan-Verisyse implantation for myopia, hyperopia, and/or astigmatism. Ophthalmology 2007;31 3. Ruiz-Moreno et al. Retinal detachment in myopic eyes after phakic intraocular lens implantation. J Refract Surg 2006;22(3): 247-52.

Catastrophic complication: Ectasia Reported Rate In Context NICE Systematic Review (April 2005) : “published ectasia case series would have been only 0.06% had modern protocols been used” Report No. of Ectasia/ No. Procedures Percentage Pallikaris JCRS 2001 19/2,873 0.66% Lyle JCRS 2001 1/332 0.30% Rad JRS 2004 14/6,941 0.20% Reinstein JRS 2006 6/5,212 0.12%

Complication Rate – Reinstein personal series FLAP COMPLICATIONS Eyes out of 11,600 % Lose 2 Lines Free Cap 1 (0.01%) 0.0000000% Thin Flap 2 (0.02%) 0.0000000% Incomplete Flap (no ablation) 6 (0.05%) 0.0000000% Corneal Perforation 0 (0.00%) 0.0000000% Blindness (total loss of vision) 0 (0.00%) 0.0000000% Corneal scarring reducing vision 0 (0.00%) 0.0000000% Inflammation with decrease of vision 1 (0.01%) 0.0000000% Infection 0 (0.00%) 0.0000000% Epithelial Ingrowth (requiring further surgery) 21 (0.19%) 0.0000000% Need for corneal transplantation 0 (0.00%) 0.0000000% Keratectasia 0 (0.00%) 0.0000000% LASER COMPLICATIONS Eyes out of 11,600 % Lose 2 Lines Visually sig. decentrations 0 (0.00%) 0.0000000% Laser parameter data entry error 3 (0.03%) 0.0000000%

Challenge: SIZING of Phakic IOL Most of the postoperative complications associated with phakic IOLs are due to poor lens sizing. Oversized and undersized lens result in complications Current standard for sizing: white-to-white + 0.50 mm However, publications report no adequate correlation between white-to-white and angle-to-angle white-to-white and sulcus-to-sulcus

Anterior Segment Correlation Publications Goldsmith JA et al. Anterior chamber width measurement by high-speed optical coherence tomography. Ophthalmology 2005. Fea AM et al. Magnetic resonance imaging and Orbscan assessment of the anterior chamber. JCRS 2005 Pop M et al. Predicting sulcus size using ocular measurements. JCRS 2001. Werner L et al. Correlation between different measurements within the eye relative to phakic intraocular lens implantation. JCRS 2004. Oh J et al. Direct measurement of the ciliary sulcus diameter by 35-megahertz ultrasound biomicroscopy. Ophthalmology 2007. Reinstein DZ et al. Correlation of Anterior Chamber Angle and Ciliary Sulcus Diameters With White-to-White Corneal Diameter in High Myopes Using Artemis VHF Digital Ultrasound. In press. JRS 2008 (online prerelease www.journalofrefractivesurgery.org)

Correlations Between Anterior Segment Diameters Angle Diameter Sulcus Diameter White-to-White Angle Diameter Multivariate 6.4% 3.0% 38.0% 32.7% 26.7% Error >0.50 mm Error >0.50 mm Sig. Variables: Angle Diameter Anterior Chamber Depth Sig. Variables: White-to-white Corneal thickness Minimum keratometry Reinstein DZ, Archer TJ, Silverman RH, Rondeau MJ, Coleman DJ. Can Conventional Anterior Segment Measurements be used to Calculate Angle-to-Angle Diameter or Sulcus-to-Sulcus Diameter? J Refract Surg. [In Press].

Anterior Segment – IOL in Recessed Sulcus OD OS

Sizing Error: ICL WTW OD = 11.5 OS = 11.5

Post-operative risks Lens Refractive Surgery Posterior Capsular Opacification Endothelial cell loss Uveitis Cataract formation Pigment Dispersion Retinal Detachment Posterior dislocation Pupillary Block Pupil ovalisation Hypertension - Glaucoma Lens rotation Glare and Halos

Complications: Poor Centration Alio et al – The Kelman duet phakic intraocular lens: 1-year results – J Refract Surg. 2007;23(9):868-79

Artisan Phakic IOL Digital image preop Slide Courtesy B Dick MD Digital image postop

Artisan Phakic IOL Wavefront OPD overall (top) and higher orders only (bottom), 6th order Digital image preop Slide Courtesy B Dick MD

Artisan Phakic IOL Wavefront OPD overall (top) and higher orders only (bottom), 6th order Digital image postop Slide Courtesy B Dick MD

Complications: Dislocation Dislocation Posterior Dislocation (vitreous) - PRL Martinez-Castillo – JRS 2004;20:773-77

Complications: PCO Monfocal IOLs: from 7.1% with hydrophobic acrylic to 31.1% with hydrophilic acrylic [1] Accommodative IOLs: 48% with the Tetraflex lens [2] Auffarth et al. Ophthalmic Epidemiol. 2004; 11(4) Wolffsohn J. Two-year performance of the Tetraflex accommodative IOL. ARVO – May 2008

Case Example: Post RLE Pre-op Rx +3.00 D OD, +3.50 D OS No sign of cataract Monovision RLE in 2003 – monofocal lenses Complained of misting vision and felt off balance 3 months post-op, LASIK to correct “off balance feeling” Visual symptoms made worse Diagnosed with PCO in 2006 Bilateral YAG capsulotomies performed No improvement in symptoms

Case Example: Post RLE Visual Symptoms Constant mist over vision day and night Halos; can’t drive at night

Case Example: Post CLE 46 yo divorced mother of 2. CLE performed Nov 2006; ReStor IOLs implanted Extremely fatigued eyes and couldn’t drive at night Extreme glare and scattering of head lights ReStor IOLs removed in Jan 2007, replaced with monofocal IOLs – 2.5 hour procedure (bilateral!) Yag capsulotomy in November 2007 Night vision improved Fatigue better but not resolved Foreign body sensation “like a piece of glass in the eye” Distance vision clear, near blurred (absolute presbyopia)

Case Example: Post CLE Pre-op Rx +5.50 -1.00 x 85 OD, +4.75 -1.50 x 95 OS Bilateral CLE in 2003; accomodating IOLs implanted Severe night vision symptoms Bilateral Yag treatment in 2005 to relieve night vision symptoms Night vision as below after Yag treatment

Case Example: Post CLE Night vision in 2008 Floaters

Case Example: Post RLE – OD Elshnig pearls Posterior capsule opacification

Case Example: Post RLE – OS Elshnig pearls Posterior capsule opacification

Endothelial cell count Artisan phakic IOL ECC decreased by 4.3% over 3 years from 2588 to 2400 cell/mm 2 (p<0.01) [1] ECC decreased by 2.3% over 6 months (p=0.15) [2] Medennium Phakic Refractive Lens ECC did not change significantly from 2620 ± 300 cell/mm 2 to 2587 ± 332 cell/mm 2 1-year post-op [3] Kelman Duet Phakic IOL [4] ECC decreased by 5.4% over 1 year from 2726 ± 376 cell/mm 2 to 2579 ± 321 cell/mm 2 (p=0.02) 17.3% of eyes had loss greater than 15% Desai et al - Long-term results of the Artisan IOL for the correction of severe and extreme hyperopia in the United States: A prospective Multi-Center Study – ARVO 2008. Pop M. Payette Y. Refractive lens exchange versus iris-claw Artisan Phakic Intraocular Lens for Hyperopia. J Refract Surg. 2004;20:20-24 Gil-Cazorla – Phakic Refractive Lens (Medennium) for correction of +4.00 to +6.00 Diopters: 1-year follow-up. J Refract Surg. 2008;24:350-4 Alio et al. The Kelman Duet Phakic Intraocular Lens: 1-year Results. J Refract Surg. 2007;23:868-878

Endothelial cell loss Unknown long-term effects of phakic IOL on the endothelium Particular risk for implants in young patients Before After phakic IOL Kim et al – Corneal endothelial decompensation after iris-claw phakic intraocular lens implantation – J Cataract Refract Surg. 2008; 34(3):517-9. Alio et al – The Kelman duet phakic intraocular lens: 1-year results – J Refract Surg. 2007;23(9):868-79 Stulting et al – Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States FDA clinical trial. Ophthalmology. 2008; 115(3): 464-472 Guell et al – Five-year follow-up of 399 phakic Artisan-Verisyse implantation for myopia, hyperopia, and/or astigmatism. Ophthalmology 2007;31 Gierek-Ciaciura et al. Correction of high myopia with different phakic anterior chamber intraocular lenses: ICARE angle-supported lens and Verisyse iris-claw lens. Graefes Arch Clin Exp Ophthalmol. 2007;245(1): 1-7.

Complications: Pupil ovalisation Alio et al – The Kelman duet phakic intraocular lens: 1-year results – J Refract Surg. 2007;23(9):868-79

Complications: Cataract Formation Garcia-Feijoo et al – JCRS – 2003;29:1932-39 Brandt JD et al – Am J Ophthalmology 2001;131:260-263 Alio et al – Angle-supported anterior chamber phakic intraocular lens explantation causes and outcome. Ophthalmology 2006;113(12): 2213-20

Uveitis/Iridocyclitis Iridocyclitis Leccisotti. Iridocyclitis associated with angle-supported phakic intraocular lenses. J Cataract Refract Surg. 2006;32(6): 1007-10. Uveitis Lackner et al –Ophthalmology 2003;110:2153-61

Complications: Synechiae Artisan +6.00

Complications: Pigment Dispersion Garcia-Feijoo et al – Ultrasound biomicroscopy of silicone posterior chamber phakic intraocular lens for myopia – J CRS – 2003;29:1932-39 Brandt JD et al – Pigmentary dispersion syndrome induced by a posterior chamber phakic refractive lens – Am J Ophthalmology 2001;131:260-263

Complications: Ocular Hypertension De Souza – Anterior chamber intraocular lens for high myopia: five year results – JCRS 2001;27:1248-1253 Verde – Medennium posterior chamber phakic refractive lens to correct high myopia – JRS 2007;23:900-904

Other Complications Zonular damage Eleftheriadis – JCRS 2004;30: 2013-16 Need for excimer laser enhancement Alio et al – The Kelman duet phakic intraocular lens: 1-year results – J Refract Surg. 2007;23(9):868-79 Haptic exchange or reposition Alio et al – The Kelman duet phakic intraocular lens: 1-year results – J Refract Surg. 2007;23(9):868-79 Glare and halos Moshirfar et al. Two-year follow-up of the Artisan/Verisyse iris-supported phakic intraocular lens for the correction of high myopia. Lens exchange due to refractive errors Guell et al – Five-year follow-up of 399 phakic Artisan-Verisyse implantation for myopia, hyperopia, and/or astigmatism. Ophthalmology 2007;31

Ease of attaining exact target refraction (enhancement)

Advantages of corneal treatment Enhancements after primary LASIK are easy to perform to obtain the target refraction Flap lift and corneal ablation Enhancements after IOL implantations: - Lens exchange - Corneal treatment for astigmatism correction - Corneal treatment for residual refraction Up 50% of re-treatments after phakic IOL [1] Gil-Cazorla R. Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 Diopters: 1-year follow-up. J Refract Surg. 2008;24:350-354 Easier to perform two treatments on the cornea

Patient Preference Patients more wary of intra-ocular surgery Thought of incisions in the eye Having to live with an artificial lens inside the eye More traumatic surgery for the patient

Simultaneously provides good visual function at distance and near

59 yo white male Plano after hyperopic treatment Excellent near vision! Laser Blended Vision: Increased Depth of Field OD Manifest BSCVA UCVA Near Pre Op +3.00 -0.75 x 115 20/20 20/63 N24 1 Year +0.25 -0.75 x 152 20/12.5 20/20 N6 OS Manifest BSCVA UCVA Near Pre Op +3.25 -0.75 x 90 20/20 20/80 N18 1 Year -0.25 -0.50 x 5 20/20 20/25 N6

Laser BV High Hyperopic LASIK +7.00 57 y.o. OD OS Binocular Pre Manifest +6.75 -0.75 x 43 +7.00 -0.50 x 120 BSCVA 20/25 20/20 6 Mo Post Enh UCVA 20/32 20/20 20/20 & N5 Manifest -1.25 sph +0.25 sph BSCVA 20/20 20/20

Laser BV High Hyperopic LASIK +7.00 Near eye Rx: -1.25 sph Expected UCVA 20/63 Actual UCVA 20/32 is equivalent to an Rx of -0.50 D For a 57 yo to read N5, an Add of +2.00 D would be required Effective depth of field for the near eye is from -0.50 D to -2.00 D -1.25 “nominal rx” -0.50 “distance” -2.00 “near”

Presbyopic Correction: Intra-Ocular

Limitations of intraocular Tx - young population Corneal treatment: Near Vision + Distance Vision correction Lens treatment Phakic IOLs: Clear Lens Extraction Loss of accommodation Limited use in the young population Long term effect on the corneal endothelium? Complications

Limitations in the presbyopic population Corneal treatment: Near Vision + Distance Vision correction Intraocular lens implant after CLE Monofocals IOLs: Poor Near Vision – No remaining Acc Multifocals IOLs : Some near vision but decreased contrast sensitivity, night vision disturbances Accommodative IOLs: limited Acc

Multifocal IOLs Discontinuous optics: simultaneous vision through a series of concentric circular bands, alternating between distance and near correction Pupil size dependent Drawbacks: Reduced contrast sensitivity Increase night vision disturbances Poor vision at certain distances

Multifocal IOLs Binocular UCVA 4 to 8% experience severe night vision disturbances [2,3] Chiam et al. Functional vision with bilateral ReZoom and ReSTOR intraocular lenses 6 months after cataract surgery. 2007;33:197-202. Kohnen et al. European multicenter study of the Acrysof ReSTOR apodized diffractive intraocular lens. Ophthalmology. 2006;113;584. Vingolo et al. Visual acuity and contrast sensitivity: Acrysof ReSTOR apodized diffractive versus Acrysof SA60AT monofocal intraocular lenses. J Cataract Refract Surg. 2007;33: 1244-47. Near Intermediate Distance ReSTOR [1] 88% ≥ 20/32 24% ≥ 20/32 46% ≥ 20/20 ReZoom [1] 44% ≥ 20/32 50% ≥ 20/32 60% ≥ 20/20 Moderate Glare Moderate Halos ReSTOR [1] 20% 14% ReZoom [1] 30% 28%

Accommodative IOLs Binocular UCVA Sanders et al. Visual Performance results after Tetraflex accommodating intraocular lens implantation. Ophthalmology. 2007;114: 1679-1684. Hancox et al. Objective measurement of intraocular lens movement and dioptric change with a focus shift accommodating intraocular lens. J Cataract Refract Surg. 2006;32: 1098-1103. Accommodative IOLs provide limited accommodative ability: Objective measurements unable to demonstrate any significant forward movement of the IOL [2] Near Distance Tetraflex [1] 48.1% ≥ 20/40 50.6% ≥ 20/20

Presbyopic Advantages of Corneal Treatment Retain Accommodation ability Dominant eye corrected for distance vision Non-dominant eye corrected for near vision Increased Depth of Focus at near and distance Intermediate zone of fusion Lower degree of anisometropia than traditional monovision Less suppression required Good binocular vision at near and distance

MEL80 Micro-Monovision Outcomes Hyperopia up to +5.75 with presbyopia

Excimer Laser for Hyperopia: Wider Limits Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth 1,2,3,4 1. London Vision Clinic, London, UK 2. St. Thomas’ Hospital - Kings College, London, UK 3. Weill Medical College of Cornell University, New York, USA 4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche), Paris, France

Slight reduction in contrast for >60 Statistical significance indicated by * Contrast Sensitivity: Stratified by Age * * * * * * * * * Analysed as change in patches e.g. loss 2 patches (-2)

Alternative: Multi-focal IOL Below normal contrast sensitivity for both ReSTOR lens types

Excimer Laser for Hyperopia: Wider Limits

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