1. Quality of Life Analysis on Near Vision Following Implantation of an AcrySof ® ReSTOR ® IOL
David T. Vroman, MD
Assistant Professor of Ophthalmology
Cornea, Cataract and Refractive Surgery
Storm Eye Institute
Medical University of South Carolina

2. AcrySof® ReSTOR® Apodized Diffractive IOL Design
Incorporates the benefits of the
AcrySof® IOL biomaterial
Integrates advanced apodized
diffractive design fundamentals
Design intended to provide...
Quality near, intermediate,
and distance vision
Increased spectacle freedom

3. Current Clinical Research
Preliminary study compared new IOL with main market rival with excellent results
US and European multi-center data used for approval
Similar larger study in USA for FDA approval – includes comparison with AcrySof® Monofocal Control
Non-Masked, Parallel Group, Non-Randomized Multi-Center Study
Bilateral Implantation of ReSTOR® or Control

4. AcrySof ® ReSTOR ® Apodized Diffractive IOL
Analysis of near vision
utilizing the AcrySof®
ReSTOR® IOL
Quality of life data was
analyzed using the modified
Cataract TyPE specification
instrument subjective
questionnaire which
measured limitations in near
vision
Acuity results include an
evaluation of near VA under
photopic and mesopic
conditions
Reading speed testing,
performed in an independent
study, demonstrate near
visual acuity as an example
of a near vision related
activity

5. Near Photopic Visual Acuity Both Eyes, 6 Month Postoperative
20/15
20/20
20/25
20/30
20/40
20/50
20/60
Mean LogMAR, VA
Best Distance, Uncorrected
Best Distance, Distance Corrected
Standard Distance, Best Corrected

6. Near Photopic Visual Acuity 1st Eye, 6 Month Postoperative
Best Distance, Uncorrected
Best Distance, Distance Corrected
Standard Distance, Best Corrected
20/15
20/20
20/25
20/30
Mean LogMAR, VA
20/40
20/50
20/60

7. Near Mesopic VA 6 Months Postoperative Distance Corrected at Best Distance
20/15
First Eye
Both Eyes
20/20
20/25
20/32
20/40
Mean LogMAR, VA
20/50
20/60
20/70

8. Limitations in Near Vision Without Glasses, Bilateral (6 month Post-op)
Extreme limitation
P <
Limitation Score
No limitation
Treatment Group

9. Spectacle Freedom: Near Vision, 6 Months Postoperative
Percentage of Subjects

10. Methods – Reading Speed
Patients with bilateral Array (n=7), AcrySof ® monofocal (n=6), ReSTOR® (n=5)
Video of patients reading a standardized paragraph at distance of their choice
Best distance and time to read each line recorded

11. 20/80 Equivalency
Total Elapsed Time
Array® Monofocal ReSTOR®

12. 20/50 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

13. 20/40 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

14. 20/32 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

15. 20/25 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

16. 20/20 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

17. 20/16 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

18. 20/13 Equivalency
Total Elapsed Time
Array ® Monofocal ReSTOR ®

19. Last Legible LogMAR VA Equivalent Font Size
Reading Speed Data
Last Legible LogMAR VA Equivalent Font Size

20. AcrySof ® ReSTOR ® Apodized Diffractive IOL Conclusions
AcrySof® ReSTOR® Apodized Diffractive IOL has received FDA approval
Interim clinical results demonstrate functional near vision under various lighting conditions
Enhances the quality of life for near vision related activities
Subjects are able to maintain a constant pace of reading speed at variable distances

21. Thank You .
ASCRS 2005