Accommodating IOL s History and Clinical Management

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1 Accommodating IOL s History and Clinical Management Bausch & Lomb Surgical Aliso Viejo, CA Genesis of an Accommodating IOL 1

2 Observations with Plate IOLs Stuart Cumming 1989 Some plate haptic IOL patients are still able to read well even after eliminating pseudoaccommodative factors such as Residual myopia Residual astigmatism Loop Haptic Plate Haptic 1989 Early Investigation Plate IOLs A-Scans on patients after pilocarpine and cycloplegic Demonstrated lens movement on 10 patients, average 0.7mm 2

Literature Search Busacca 1955 - (Annales D

anteriorly Ciliary muscle mass encroaches on

3 Literature Search Busacca (Annales D Oculistique) Young aniridic patient Gonioscopy Ciliary muscle constriction and relaxation Insertion of zonules moves anteriorly Ciliary muscle mass encroaches on vitreous cavity Coleman 1986 Tr. Am. Ophth. Soc. Ten Primates 3

4 Thornton 1986 Current Canadian Ophth.Pract. A-Scan demonstrated shallowing of anterior chamber after movement of three piece loop lens with accommodation Crystalens Evolution

Early Clinical Evaluations The first Crystalens AIOL was implanted in England in 1991 6 lens designs

Crystalens AT-45 The First FDA Approved Accommodating IOL Nov.

5 Early Clinical Evaluations The first Crystalens AIOL was implanted in England in lens designs implanted over 9 years Summary: All models accommodated All models had some anterior dislocations Crystalens AT-45 The First FDA Approved Accommodating IOL Nov Hinged optic to increase movement Lengthened haptics to maximize amplitude 4.5 mm optic to maintain 10.5mm plate length 11.5 mm overall length 5

6 Primary Mechanism Optic Movement UBM Relaxed Increased Pressure Constricted Secondary Mechanism Accommodative Arching 6

Summary of Wavefront Findings crystalline

in negative spherical aberration Increase

7 Summary of Wavefront Findings crystalline Lens Power Change Greater in the center Less in the peripheral Generally greater than the change in SE Aberration Increase in negative spherical aberration Increase in coma MRI Changes to the Lens Far Near Distance Near 7

Summary Of Wavefront Findings Crystalens

8 Summary Of Wavefront Findings Crystalens Power Change Greater in the center Less in the peripheral Generally greater than the change in SE Aberration Increase in negative spherical aberration Increase in coma MRI Changes to Optic Distance Near 8

9 Design Enhancements Crystalens AT-45SE August degree square edge Round to the right loop configuration 9

10 Crystalens Five-O November mm optic diameter Parallel plate design Greater plate coverage Enhanced optic and plate translation Square edge Two lengths 11.5 mm for powers 17.0 D and above 12.0 mm for powers below 17.0 D Benefits Reduction in the potential for posterior capsular opacification Easier to inject the IOL into the eye during surgery 10

11 Benefits Increased capsular stability Allows for better predictability and targeting of the refractive outcome Crystalens HD Approved by the FDA in July 2008 and CE marked in August 2008 Follows 3 generations of FDA approved accommodating intraocular lens(4 th generation) First generation FDA approved in 2003 Depth of Crystalens HD central optic is slightly thicker than previous models enhancing the central power change that is observed when the Crystalens accommodates 11

Introducing the AO Crystalens AO is the only aspheric accommodating lens in the world This lens takes the best of the aspheric portfolio and combines it with our successful Crystalens platform CAO

12 Introducing the AO Crystalens AO is the only aspheric accommodating lens in the world This lens takes the best of the aspheric portfolio and combines it with our successful Crystalens platform CAO can improve a patient s vision through an increase in contrast sensitivity due to the absence of spherical aberration and other higher-order aberrations Crystalens AO Properties Made of a 3 rd generation silicone material called Biosil Modified plate-style implant with a 5 mm optic (Available in two overall lengths 11.5 mm for powers 17.0 D and higher 12.0 mm for powers below 17.0 D) 12

Crystalens AO Properties Has 2 polyimide loop haptics at the end of each plate

positioning of the lens Hinges are present at the junction of the (optic) and

Crystalens AO Properties 360 square edge design of the posterior surface of

13 Crystalens AO Properties Has 2 polyimide loop haptics at the end of each plate One is round and the other is oval to facilitate correct anterior/posterior positioning of the lens Hinges are present at the junction of the (optic) and plate on each side to enable forward vaulting of the implant with accommodation Crystalens AO Properties 360 square edge design of the posterior surface of Crystalens HD Optic has a 360 square edge design to impede posterior capsule opacification 13

$Crystalens AO is the premium IOL that works best for the growing number of post refractive and RK patients The lens is free of$

14 Crystalens AO An intraocular lens free of spherical aberration will provide for more precise focusing of light on the retina The aberration-free aspheric design reduces spherical aberration and makes the lens immune to the effects of decentration Provides a full range of vision near, far and intermediate vision with exceptional visual quality Minimizes dysphotopsias such as glare The Crystalens AO is the premium IOL that works best for the growing number of post refractive and RK patients The lens is free of glistenings Specs 14

15 Clinical Management Patient Selection, Pre-op, Surgical, Post-op Indications Primary implantation for the visual correction of aphakia in adult patients with cataracts Provide improved near, intermediate, and distance vision without spectacles 15

Patient Selection The Ideal Candidate Physical Attributes Cataract patients with need for

$75 D Post corneal refractive surgery patients?$ Some surgeons have named Crystalens the premium lens of choice Astigmatism correction

16 Patient Selection The Ideal Candidate Physical Attributes Cataract patients with need for bilateral implantation Especially hyperopes Good ocular health Potential for good visual acuity in each eye Good binocularity Corneal astigmatism? Plan for treatment if over 0.75 D Post corneal refractive surgery patients? Some surgeons have named Crystalens the premium lens of choice Astigmatism correction Limbal Relaxing incisions (LRI) Done at time of IOL implant LASIK / PRK Done after lens implant Sx PRK can be as soon as 6 weeks Lasik 3 months 16

17 Patient Selection The Ideal Candidate Psychological Attributes Realistic expectations Psychologically stable Patient Profile 17

examination Rule out endothelial l disease such as Fuchs dystrophy Test for dry eye disease Dilated fundus examination Rule out

18 Pre-op K readings Manual keratometer Obtain consistent, high quality measurements prior to any drops being applied to the eye If patient is a contact lens wearer insure that contacts have been out long enough to allow for a stable (cornea) Slit lamp examination Rule out endothelial l disease such as Fuchs dystrophy Test for dry eye disease Dilated fundus examination Rule out macular degeneration or significant diabetic retinopathy as examples of poor candidates Consistency? Obtain consistent, high quality measurements 18

19 Surgical Routine cataract Allows for small incision cataract surgery Sub 3mm incision (Rhexis size of 5.5 mm to 6.0 mm) Insertion 19

$stabilize at 2 weeks If UCVA is < 20/40 at distance; refract$ patient If BCVA does not improve, dilate and rule out CME Ideal

20 Post-op Distance vision stable at 1 week Near vision begins to stabilize at 2 weeks If UCVA is < 20/40 at distance; refract patient If BCVA does not improve, dilate and rule out CME Ideal Posterior Positioning Iris Anterior Capsule crystalens One Day Post-op 20

21 Post-op Post-op: days post-op Keratometry Uncorrected distance, intermediate, and near visual acuity Controlled maximum plus refraction Distance and near visual acuity through distance correction Gradual PBU to J1 to determine add. Verify refractive findings with a cycloplegic refraction If VA s and refraction do not correlate If near visual acuity is worse than J3 Why K s Post-op? Predictive of refractive cyl A measure of success of astigmatic management Indicates if additional procedure may be necessary 21

22 Why a Detailed Refractive Analysis? This is a refractive procedure Refine outcomes Patients can accommodate It is easy to be fooled Example Crystalens OD Standard IOL OS 22

23 Example Crystalens OU Post-Operative Refraction Pearls In the initial post-operative p period, the accommodative change between distance and near may be slow. Refract your Crystalens patients as you would a young myope different from routine regular monofocal IOL post-ops. To prevent accommodative spasm, instruct the patient not to read before the examination and evaluate all distance measurements before taking intermediate and near acuities. 23

24 Post-Operative Refraction Pearls Measure the uncorrected distance vision (UCDVA) giving the patient time to blink and focus Auto-refractors tend to over-minus, DO NOT use this sphere as your starting point It is very important to use the intermediate and near vision acuity charts provided by B & L Intermediate and Near Vision Acuity Charts (B&L) 24

25 Accommodative Rehabilitation crystalens patients must challenge their near vision Reassure that reading gets better with time Do not force reading during 1 st week postop Patients should use reading glasses Reading exercise (word search) booklets are given 1 week after the second eye is done Explain how to use word search booklets Co-management Model 25

26 Important Points Co-management arrangements must be based on the surgeon s portion of the total t fee Typically ASC charges are not part of the arrangements Arrangements must be based on procedures performed by the each provider Clinical Findings 26

Log Contrast Sensitivity Mesopic Illumination (3 cd/m 2 ) CrystaLens N=126

6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 1.80 1.73 1.61 1.59 1.40 1.25 1.09 0.96 0.72 0.

2 1 0.8 0.6 0.4 0.2 0 1.77 1.70 1.53 1.57 1.

27 Log Contrast Sensitivity Mesopic Illumination (3 cd/m 2 ) CrystaLens N=126 Standard N=64 CrystaLens N=126 Standard N=64 lo og contrast sensitivity cpd 3cpd 6cpd 12cpd 18cpd contrast sensitivity log c cpd 3cpd 6cpd 12cpd 18cpd Without Glare 3 Lux Glare Webster s Unabridged Dictionary 8pt 8pt 27

Lenses Addressing Presbyopia ReSTOR ReSTOR Aspheric

Accommodative Crystalens-the only FDA approved

$favor of the Tecnis Multifocal Diffractive ReSTOR IQ 4.$

28 Lenses Addressing Presbyopia ReSTOR ReSTOR Aspheric Crystalens Tecnis MF Presbyopic IOLs Available in the U.S. Accommodative Crystalens-the only FDA approved accommodating IOL Multifocal ReZoom-AMO use is waning in favor of the Tecnis Multifocal Diffractive ReSTOR IQ 4.00 add. Use is decreasing due to ReSTOR 3.00 D add. Tecnis Multifocal (4.00 D add) 28

$diffractive design AMO claims: Pupil independence Good vision in all$ levels of light AcrySof ReSTOR Aspheric IOL SN6AD3 Add Power: +4 D

2 D Range: +10 D to +34 D Hydrophobic Acrylic A-Constant: 118.9 Neg.

29 Tecnis Multifocal IOL Features/Benefits Non-apodized full optic diffractive design AMO claims: Pupil independence Good vision in all levels of light AcrySof ReSTOR Aspheric IOL SN6AD3 Add Power: +4 D Spectacle Plane: 3.2 D Range: +10 D to +34 D Hydrophobic Acrylic A-Constant: Neg. Spherical Aberration SN6AD1 Add Power: +3 D Spectacle Plane: 2.4 D Range: +10 D to +34 D Hydrophobic Acrylic A-Constant: Neg. Spherical Aberration 58 29

$AcrySof ReSTOR IOL FDA approval March 2005 apodized diffractive$ $& near vision Diffraction refraction A type of wave interference$ $Diffractive Optic Apodization: reduction in diffractive step$ $6 mm diameter diffractive region Steps reduce from 1.$

30 AcrySof ReSTOR IOL FDA approval March 2005 apodized diffractive optic ReSTOR IOL incorporated with refraction achieves distance & near vision Diffraction refraction A type of wave interference Waves bend and spread when they meet an obstruction Apodized Diffractive Optic Apodization: reduction in diffractive step heights from center to periphery of 3.6 mm diameter diffractive region Steps reduce from 1.3 microns to 0.2 microns gradual energy blend between powers 3.6 mm 1.3 micron step Original magnification 80 X 30

$Accommodating Diffractive focus$ IOL Quality of Vision NB:

31 Review of Presbyopic IOLs: What Do You Get? Accommodating Diffractive focus Multifocal near focus far focus IOL Quality of Vision NB: Resolution of the human eye is between 6 and 20 cycles/mm 31

MTF Explained In a study of modular transfer function (MTF) using a 3 mm aperture, Crystalens demonstrated enhanced resolution

Crystalens HD and Five-O show improved MTF performance over multifocal lenses The Five-O and Crystalens HD show similar results

height of the curve Monofocal accommodating IOLs demonstrates a superior quality of vision For patients who require cataract

premium visual quality at all distances First and only FDA-approved accommodating IOL Mimics natural focusing action of the eye

32 MTF Explained In a study of modular transfer function (MTF) using a 3 mm aperture, Crystalens demonstrated enhanced resolution The measurements are made at a 3 mm aperture; the MTF measurements are also made at 3 mm, per the ISO standard The Crystalens HD and Five-O show improved MTF performance over multifocal lenses The Five-O and Crystalens HD show similar results to each other AcrySof ReSTOR & ReSTOR Aspheric show similar performance levels to each other Quality of vision is defined by the height of the curve Monofocal accommodating IOLs demonstrates a superior quality of vision For patients who require cataract lens replacement A COMPLETE FIELD OF VISION Mimicking natural accommodative arching, Crystalens HD is designed to deliver premium visual quality at all distances First and only FDA-approved accommodating IOL Mimics natural focusing action of the eye Provides single focal point Modified optic increases focal range No compromise to contrast sensitivity Provides 100% of light rays 100% of the time 32

Pupil size declines with age Diminished efficacy of ReSTOR Aspheric over time 4 As patients age,

smaller pupils can have further comprised quality of vision if they develop future ocular disease

$requires pupil p enlargement With a 3 mm pupil at plano refraction, Crystalens HD demonstrates$

33 Pupil size declines with age Diminished efficacy of ReSTOR Aspheric over time 4 As patients age, their pupil size declines limiting the benefits they receive from the ReSTOR Aspheric Patients with smaller pupils can have further comprised quality of vision if they develop future ocular disease such as AMD THE MEASURE OF OPTIC ADVANCEMENT The only IOL approved by the Federal Aviation Association, Crystalens HD demonstrates premium visual quality at average pupil p size ReSTOR requires pupil p enlargement With a 3 mm pupil at plano refraction, Crystalens HD demonstrates superior distance image quality 10 33

34 Distance Image Quality in Mesopic Conditions mm Aperture ReSTOR Aspheric +3 D TECNIS* MF IOL ACRI.LISA* 366D ReSTOR Aspheric +4 D REZOOM* IOL Crystalens HD MTF measured with model eye at 100 lp/mm. All IOL powers range from 20.0D to 22.0D 67 Data on File. Bausch & Lomb *Trademarks are property of their respective owners. ReSTOR Pl warnings underscore the visual impairments associated with a multifocal IOL 7 WARNINGS: 1. Some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or radial lines around point sources of light under nighttime conditions. 2. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, multifocal patients should exercise caution when driving at night or in poor visibility conditions. 34

35 Improved night vision is crucial to the safety of senior citizens Nineteen million drivers in the US (9%) are senior citizens- a figure expected to rise to 30 million by Drivers age 75 have a 37% higher crash rate than younger drivers and the highest probability of resultant injury and mortality of any age group 9 Diminished night vision is considered the most serious physical disability of elderly drivers 9 Background on Initial Crystalens AO Eval Surgeons 30 US, 1 DR, 5 EU, 1 NZ Numbers 300 eyes implanted during the first month after launch Report 1 month results Guidelines 10 eyes per surgeon 5 bilaterally implanted patients Good potential vision in each eye IOL powers between 16 D and 27 D Moderate to high astigmats excluded Only eyes with less than 1.50 D of corneal astigmatism Good ocular health No previous ocular surgery Including post corneal refractive 35

36 Current Results Eyes Reported 194» 44 at 2 weeks» 150 at 1 month Number of bilateral cases reported on 78 Monocular UCDVA Crystalens AO n=194 ReSTOR +3 n=984 Tecnis n= % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 95% 87% 85% 90% 75% 67% 65% 44% 46% 37% 25% 20% 20/20 or Better 20/25 or Better 20/30 or Better 20/40 or Better AO Mean P.O. SE Standard Deviation

Monocular UCNVA Crystalens AO Crystalens AO n=194 ReSTOR 3+ n=899 Tecnis n= 169 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 65% 62% 94% 91% 91% 83% 80% 70% 35% J1 or Better J2 or Better J3 or Better

37 Monocular UCNVA Crystalens AO Crystalens AO n=194 ReSTOR 3+ n=899 Tecnis n= % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 65% 62% 94% 91% 91% 83% 80% 70% 35% J1 or Better J2 or Better J3 or Better Binocular Acuities 1 Month Post-op n= 78 Distance Intermediate Near 100% 90% 80% 87% 91% 97% 94% 100% 100% 96% 70% 60% 65% 50% 55% 40% 30% 20% 10% 0% 20/20 or Better D and I J1 or Better N 20/25 or Better D and I J2 or Better N 20/30 or Better D and I J3 or Better N 37

$Better N 20/25 or Better D and I J2 or Better N 1 patient with PCO OU 20/30 or Better D and I J3 or Better N Refractive Stability Refractive Stability (N = 105) 40% 39% Mean 0.011 35% Std Dev 027 0.$

38 Binocular Acuities 1 Month Post-op n= 5 Patients 10 eyes Distance Intermediate Near 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 80% 100% 100% 100%100% 100% 100% 100% 60% 20/20 or Better D and I J1 or Better N 20/25 or Better D and I J2 or Better N 1 patient with PCO OU 20/30 or Better D and I J3 or Better N Refractive Stability Refractive Stability (N = 105) 40% 39% Mean % Std Dev % 25% 26% Min Frequency 20% 20% Max % Within +/ D 81.0 % 10% 8% Within +/ D % 5% 4% 0% < % 1% to to to to to to SE Difference Between 2w and 1m Visits to % > % 38

39 Estimated Total Accommodation Estimated Accommodation Based on BCDVA and DEQ for Near Frequency 60% 50% 40% 30% 59% Mean 1.74 Std 0.41 Dev Min 0.68 Max 2.85 > 0.5 D % > 1.0 D 94.2% 24% 20% 12% 10% 6% 0% 0% < to 1 1 to to 2 2 to 2.5 Estimated Accommodation (D) Significance of DCI and DCN Findings 2+ Weeks Post-op Five-O n= 622 Crystalens AO n= % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 20/20 or Better 20/25 or Better 20/30 or Better 20/40 or better 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Five-O n= 837 Crystalens AO n=127 J1 oe Better J2 or Better J3 or Better 39

40 Achieved Spherical Equivalent vs Intended Target n= 186 (8 targets not recorded) to to to to to to UCVA Comparisons Distance acuities similar Intermediate acuities superior with Crystalens s HD intermediate acuities extremely good Monocular near acuities better with ReSTOR s HD somewhat better than Five-O Binocular near acuities with HD similar to ReSTOR s 40

41 DCNVA AT-45 Clinical Trial Population 1 Year vs 7 years 1 Year (n=46) 7 Years (n=46) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 93% 98% 67% 56% 26% 13% J1 or Better J2 or Better J3 or Better Handheld Electronic Device Use is Increasing 41

4 hours per day By 2015, the population of those over the age of 50 will reach 106

42 Computer Usage in 50+ Age Group 43% of the 79 million adults over 50 currently use the internet hours per week That is 1.6 to 4.4 hours per day By 2015, the population of those over the age of 50 will reach 106 million Sources: Jupiter Communications.2002 U.S. Census Bureau. Do not underestimate the importance of good intermediate vision 42

43 Monocular UCIVA Crystalens AO Crystalens AO n=194 ReSTOR 3+ n=653 Tecnis n= % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 98% 100% 93% 77% 72% 69% 62% 62% 44% 48% 30% 23% 20/20 or Better 20/25 or Better 20/30 or Better 20/40 or Better Conclusions All three presbyopic lenses deliver as designed Provide improved distance and near vision without spectacles The Crystalens provides a unique set of post-op results for the cataract patient Excellent quality of vision i Unsurpassed combination of distance, intermediate, and near visual acuity Lens function is not pupil dependent 43

44 Future Accommodating IOLs Visiogen Synchrony Dual Optic Minus power posterior lens Plus power anterior lens Distance between optics increases with accommodative effort Probable approval: Dec 2009 March 2010 Patent issues could arise 44

Crystalens AO offers the largest sweet spot ; i.e., the Crystalens AO is more tolerant of defocus and will be a more forgiving lens.

45 Lenstec Tetreflex Monofocal Design Translating optic Probable Approval: Dec 2009 March 2010 Patent issues could arise Crystalens AO The Crystalens AO delivers the highest quality of vision to the widest range of patients and provides surgeons more flexibility. Crystalens AO offers the largest sweet spot ; i.e., the Crystalens AO is more tolerant of defocus and will be a more forgiving lens. The Crystalens AO will have fantastic intermediate and distance vision. The near will be better than the Crystalens 5.0 but not as good as the Crystalens HD lens. 45

Crystalens AO Goals The goal with the launch of the Crystalens AO is to position this lens as one that can improve a patient s post operative vision through an

lens in the world This lens takes the best of our aspheric portfolio and combines it with our successful Crystalens platform.

46 Crystalens AO Goals The goal with the launch of the Crystalens AO is to position this lens as one that can improve a patient s post operative vision through an increase in contrast sensitivity due to the absence of spherical aberration and other higher-order aberrations Crystalens AO is the only aspheric accommodating lens in the world This lens takes the best of our aspheric portfolio and combines it with our successful Crystalens platform. Why will AO provide better vision than 5.0? Less spherical aberration Immune to effects of lens decentration Better tolerates effects of lens tilt More consistent outcomes Crystalen ns AO Crystalens s

47 Why will AO provide better vision than 5.0? Less spherical aberration Immune to effects of lens decentration Better tolerates effects of lens tilt More consistent outcomes Crystalens AO Tecnis Centere d Decenter ed 0.5 mm Decente red 1.0 mm 20/20 Letter E, 4-mm Pupil Why will AO provide better vision than 5.0? Less spherical aberration Immune to effects of lens decentration Better tolerates effects of lens tilt More consistent outcomes 5.0 Tilt = 0º Tilt = 5º Tilt = 10º HD Tilt = 0º Tilt = 5º Tilt = 10º AO Tilt = 0º Tilt = 5º Tilt = 10º 20/20 Letter E, 4-mm Pupil 47

48 Conclusions Crystalens AO will be an excellent addition to the Crystalens portfolio Crystalens AO will deliver on both the quality and quantity of vision promises Discussion 48

49 Thank you Disclaimer This is a resource intended for use by physicians and other health care professionals involved in patient care. It is not intended and should not be construed as medical advice, nor is it intended to replace medical and clinical data contained. This is intended to supplement the knowledge of physicians and other health care professionals involved in patient care. The absence of a warning for a given procedure, technique, or suggestion contained should not be construed to indicate that such procedure, technique or suggestion is safe, appropriate or effective in any given patient. 49

NOW. Approved for NTIOL classification from CMS Available in Quar ter Diopter Powers. Accommodating. Aberration Free. Aspheric.

NOW. Approved for NTIOL classification from CMS Available in Quar ter Diopter Powers. Accommodating. Aberration Free. Aspheric. NOW Approved for NTIOL classification from CMS Available in Quar ter Diopter Powers Accommodating. Aberration Free. Aspheric. Accommodation Meets Asphericity in AO Merging Innovation & Proven Design The