LASIK 2008: Focusing on Patient Satisfaction and Quality of Life Issues

1. LASIK 2008: Focusing on Patient Satisfaction and Quality of Life Issues RICHARD L. ABBOTT, M.D. THOMAS W. BOYDEN HEALTH SCIENCES PROFESSOR OF OPHTHALMOLOGY UNIVERSITY OF CALIFORNIA SAN FRANCISCO SECRETARY FOR QUALITY OF CARE AND KNOWLEDGE BASE DEVEOPMENT AMERICAN ACADEMY OF OPHTHALMOLOGY

2. FINANCIAL DISCLOSURE • I have no financial interests or relationships to disclose

3. PATIENT DEMOGRAPHICS • Nearsightedness (myopia), farsightedness (hyperopia), astigmatism and presbyopia afflict approximately 40% or more of the US population. • These conditions are associated with measurable negative impacts upon quality of life and require correction with glasses, contact lenses, or surgery.

4. BACKGROUND • Lasik first approved by FDA in 1998 • Performed “off-label” since early 1990s • Millions of procedures have been performed • More than 90 percent of people who have Lasik achieve somewhere between 20/20 and 20/40 vision without spectacles or contact lenses • Complication rate is low and satisfaction rate is high

5. TECHNOLOGY IMPROVEMENTS • Corneal topography • Customized (wave-front) laser treatment • Laser assisted flap creation • Medications for post-operative management

6. WORLDWIDE PUBLISHED PEER REVIEWED STUDIES SHOW DATA REFLECTING A HIGHER THAN 95% IMPROVEMENT IN QUALITY OF LIFE FOLLOWING LASIK SURGERY

7. ALTHOUGH THE VAST MAJORITY OF PATIENTS ARE SATISFIED WITH THE OUTCOME OF THEIR LASIK SURGERY, THE DISSATISFIED PATIENT IS A VERY REAL CONCERN FOR THE LASIK SURGEON AND ORGANIZED OPHTHALMOLOGY

8. FDA OPHTHALMIC DEVICES PANEL MEETING APRIL, 2008 • Not a discussion of Lasik safety or effectiveness • Forum to discuss patient’s post-Lasik quality of life issues • Held in cooperation with the AAO and other professional organizations • Goal was to understand more about the events which lead to some Lasik patients experiencing outcomes that do not meet their expectations and how this may impact their QOL post-Lasik surgery

9. QUALITY OF LIFE • QOL is different than “safe and effective” • Refers to a patient’s ability to perform activities of daily living. • It includes: • Impact on daily routines • Family life activities • Career and sports performance • Driving (especially at night) • Confidence in personal appearance • Improvement in personal safety

10. PATIENT EXPECTATIONS • Extremely important for surgeon to understand • Must be realistic! • 20/20 vision is not the same for everyone • Functional night and driving vision may not be same as the vision that was measured in an office setting

11. THE FDA IS SEEKING TO FURTHER QUALIFY AND STUDY THE CHANGES IN QOL IN THOSE PATIENTS WHO ARE DISSATISFIED WITH THE SURGERY

12. PROPOSED NATIONAL PROSPECTIVE STUDY • Investigate: • Level of patient satisfaction • Changes in patient quality of life • Factors associated with satisfaction after Lasik • Working with FDA on study details • Time line approximately 3 years • Detailed questions should be directed to the FDA

13. FOR THE PUBLIC Refractive surgery patient information materials ACADEMY LASIK RESOURCES

14. FOR THE PUBLIC “Is Lasik for me?” – A new consumer guide ACADEMY LASIK RESOURCES

15. FOR THE PUBLIC Section on Lasik and refractive surgery: www.geteyesmart.org “K Card”: Important information for future possible cataract surgery and vision care ACADEMY LASIK RESOURCES

16. K CARDPRE AND POST-OPERATIVE REFRACTIVE SURGERY INFORMATION

17. ACADEMY LASIK RESOURCES • FOR CLINICIANS (ACADEMY MEMBERS) • EyeSmart campaign materials • Educational materials about the procedure • OMIC informed Consents and Risk Management information • K card (as noted previously)

18. ACADEMY LASIK RESOURCES • FOR THE MEDIA: • Science Writers Guide to Lasik and Refractive Surgery • Available in Newsroom • www.geteyesmart.org

19. THANK YOU!!