Synchrony AIOL Key Features

Transcription

1 Synchrony AIOL Key Features Spacers Provide consistent separation distance at emmetropia Prevent lens adhesion

2 Synchrony AIOL Key Features Spring Haptics Bias the system open Provide consistent separation force Optimized movement

3 Synchrony Preloaded Injector Single-use, disposable Easy to use Controlled release Consistent delivery Current incision size 3.6mm - 3.8mm

4 Synchrony Dual Optic Accommodating IOL Synchrony AIOL At distance the 2 optics are close together providing emmetropia When the ciliary body contracts, reducing capsular bag and zonular tension, the anterior lens moves forward, changing the eye s focus to near & intermediate

5 Implantation Technique Insert injector tip to CCC edge Release 1st optic Open capsular bag by pushing leading optic against the posterior capsule Deliver 2nd optic into capsular bag

6 Synchrony Surgical Focal Points

7 Synchrony Surgical Focal Points

8 OcuSeal (BVI) Hydrogel Liquid Bandage

9 OcuSeal (BVI) Hydrogel Liquid Bandage

10 Synchrony AIOL - Commercial Update CE Mark Approved Controlled release of product Commercially available in Spain, Germany, Italy Encouraging results to date Incorporating feedback to optimize full launch PMA submission under review with FDA Ongoing post-market clinical studies Implanted in over 1,300 eyes

11 Synchrony AIOL Clinical Results Clinical Results

12 Synchrony IOL : six month experience 16 eyes of 12 patients Mean Age ± 5.41 Mean Preoperative BCVA 0.50 ± 0.46 Mean Preoperative Sphere equivalent 0.35 ± 0.63 Incision Size : 4.1/ 3.75 mm using calibrate metal knive

13 Synchrony UCVA and BCVA 16 Eyes 1 0,9 UCVA 0, ,9 0,89 BCVA 1 1 0, ,8 0,8 0,7 0,7 0,6 0,58 0,6 0,57 0,5 0,4 0,38 0,4 0,5 0,4 0,3 0,2 0,2 0,3 0,2 0,1 0 1 Week PO 2 Weeks PO 3 Weeks PO 1 Month PO 2 Months 3 Months Po Po 0,1 0 Preop 1 Week PO 2 Weeks PO 3 Weeks PO 1 Month PO 2 Months Po 3 Months Po

14 Synchrony Binocular Near Visual Acuity 20/20 CORRECTION PREOP sf 1 WEEK PO WEEKS PO WEEKS PO MONTH PO MONTHS PO 16 0

15 Synchrony Dual Optics IOL: Sphere Equivalent vs Post Op Time 16 eyes 2 1,5 D I O P T E R S 1 0,5 0-0,5-1 -1,5-2 0,43-2,33-2, ,39-0,27-0,1-2,5-3 Preop 1 Week PO 2 Weeks PO 3 Weeks PO 1 Month PO 2 Months PO 3 Months PO

16 % Patients QOL Survey Spectacle Independence - Do you wear glasses? 76.7% 77% of patients were completely spectacle-free 14% used glasses for less than 2 hrs/day 14% 9.3% N = 43 and mainly for nearvision activities MP3019 Alarcon, MD Bohorquez, MD 2008 ESCRS

17 % Patients QOL Survey Spectacle Independence for Near Tasks Do you use reading glasses for these activities? % 88% 70% Over 85% of patients can use computers or read newspapers without glasses Work With a Computer 14% 12% Read Newspaper or Menu No Yes 30% Read Fine Print N = 43 70% can read fine print (e.g., medication labels) without reading aids Good correlation with previous question on spectacle independence MP3019 Alarcon, MD Bohorquez, 102 MD 2008 ESCRS

18 Contrast Sensitivity and Control Values Control values for CS are derived from Hohberger paper B. Hohberger et al. Measuring contrast sensitivity in normal subjects with OPTEC 6500: influence of age and glare Graefes Arch Clin Exp Ophthalmol, 2007; 245: Daytime condition healthy phakic subjects for the following age groups: <30; 30-39;40-49;50-59; 60 Functional Image Analyzer OPTEC 6500P Daytime (85 cd/m 2 ), Nighttime (3 cd/m 2 ) and Nighttime with Glare Monocular testing Paper demonstrated strong age dependence of CS with age

19 Functional Vision Analyzer STEREO OPTICAL

20 Contrast Sensitivity and Control Values CS values per age groups were provided for Daytime condition and CS Range for all ages (>18) and Average for 60 are used as Control CS Values CS Ranges for all ages (>18) were provided for Nighttime condition with and without Glare, The values are used as Control CS

21 Optivis contrast sensitivity Daytime, Nighttime and Nighttime with glare

22 ReZoom contrast sensitivity Daytime, Nighttime and Nighttime with glare

23 Log Contrast Sensitivity Log Contrast Sensitivity Contrast Sensitivity Photopic (with Glare) n = Mesopic (with Glare) n = Synchrony Restor Spatial Frequency (cycles/ degree) 0.4 Synchrony Restor Spatial Frequency (cycles/ degree) Contrast Sensitivity in mesopic & photopic conditions MP3019 John Vukich, MD ASCRS 2009

24 Acrilisa contrast sensitivity Daytime, Nighttime and Nighttime with glare

25 Acrilisa Toric IOL contrast sensitivity Daytime, Nighttime and Nighttime with glare

26 Synchrony contrast sensitivity Daytime, Nighttime and Nighttime with glare

27 Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Daytime Conditions (85 cd/m2) *B. Hohberger, et al."measuring Contrast Sensitivity in normal subjects with OPTEC 6500: Influence of Age and Glare", Graefes Arch Clin Exp Ophthalmol (2007) 245: Data from Fig. 2 Contrast Sensitivity (logmar) Contrast Sensitivity (logmar) Mean Age 69.6 Control Age >60* 2,50 2,00 Upper Range, Age >18* Lower Range, Age >18* 1,50 1,00 0,50 0,00 1, Spatial Frequency (Cycles Per Degree) 2,50 Synchrony IOL Mean Age: 69 Control Age >60* Upper Range, Age >18* 2,00 Lower Range, Age >18* 1,50 1,00 0,50 0,00 1, Spatial Frequency (Cycles Per Degree)

28 Contrast Sensitivity (logmar) Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Nighttime Conditions (3 cd/m2), No Glare *B. Hohberger, et al."measuring Contrast Sensitivity in normal subjects with OPTEC 6500: Influence of Age and Glare, Graefes Arch Clin Exp Ophthalmol (2007) 245: ,5 1 Mean Age 69.6 Upper Range, Age >18* Lower Range, Age >18* 0,5 0 1, Spatial Frequency (Cycles Per Degree) Synchrony IOL Mean Age: 69 Contrast Sensitivity (logmar) 2,50 2,00 1,50 1,00 0,50 0,00 1, Spatial Frequency (Cycles Per Degree) Upper Range, Age >18* Lower Range, Age >18*

29 Contrast Sensitivity (logmar) Contrast Sensitivity (logmar) Monocular Contrast Sensitivity Testing (Functional Image Analyzer testing) Nighttime Conditions (3 cd/m2), With Glare *B. Hohberger, et al."measuring Contrast Sensitivity in normal subjects with OPTEC 6500: Influence of Age and Glare", Graefes Arch Clin Exp Ophthalmol (2007) 245: Mean Age ,00 1,50 Upper Range, Age >18* Lower Range, Age >18* 1,00 0,50 0,00 1, Spatial Frequency (Cycles Per Degree) 2,50 2,00 1,50 1,00 0,50 0,00 Synchrony IOL 1, Mean Age: 69 Upper Range, Age >18* Lower Range, Age >18* Spatial Frequency (Cycles Per Degree)

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31 European Society of Cataract and Refractive Surgery 29 th International Congress Vienna, Austria Reed Messe Congress Center September 2011 Are Clear Corneal Incisions Safe? I. Howard Fine, MD Clinical Professor of Ophthalmology Casey Eye Institute Oregon Health & Science University

32 Financial Disclosures Consultant AMO *Calhoun Vision Travel/Research Support B & L *Vision Solutions Technologies *stock options

33 ICCE Loupes no intraocular maneuvers Large Incisions 4-7D astigmatism 5-0 silk/gut cheese wire/break Complications endo damage shallow/flat chamber iris prolapse peaked pupils Long Hospital Stay

34 10-0 mono-filament nylon suture (late 1960s) High tensile strength Inert Elastic No tactile feedback

35 Major Improvements Outpatient surgery less disruptive dramatic cost reduction ASC full Hx & PE ancillary costs (EKG, X-ray, lab) competition for OR time fully trained & committed OR staff efficiency & comfort turn over time

36 Major Improvements Room cost for cataract surgery Eugene, OR, 1974 Inpatient Outpatient $1,000+ $48

37 Major Improvements Microsurgery precision transfer of skills film video DVD internet globalization of ophthalmology

38 ECCE with automated cortex removal Precise intraocular manipulation Segregated ant. segment/post. segment corneal retinal inflammation syndrome Improved IOL support - PC IOLs Smaller incision (9 mm)

39 New Techniques in Incision Construction Reduce astigmatism scleral flap scleral tunnel single stitch self sealing scleral tunnel

40 Scleral Tunnel Incision Construction