Results of FDA study for Lasik eye surgery
Preliminary results of the USA Eyes CORE Lasik patient surgery at the US Food & Drug Administration (FDA)
Ophthalmic Devices Panel (ODP), which was considering quality of life issues after Lasik.
● 99% report quality of life as expected, better, or much better
● 98% day vision as expected, better, or much better
● 98% no complications or issues are seldom problematic
● 98% would recommend surgery to family and friends
● 97% would have surgery again, knowing what they know now
● 96% wear corrective lenses as often as expected, less, or much less than expected
● 96% report postop vision without lenses as expected, better, or much better than expected when compared to preop
vision with lenses
● 96% report overall quality of vision as expected, better, or much better than expected
● 91% no complications at any time
● 91% night vision as expected, better, or much better
● 7% complications seldom problematic (yet 91% of these same patients would have surgery again)
● 2% complications frequent or always problematic (yet 22% of f these same patients would have surgery again)
Between 1998 and 2006
The FDA received a total of 140 comments relating to LASIK dissatisfaction,
representing less than 1 in 10,000 US LASIK patients.
In 2007
Re-evaluated symptoms and satisfaction data and reaffirmed that while the vast
majority of LASIK patients were indeed satisfied with their outcomes, a few were not.
In April 2008
The FDA held hearings on LASIK complications. To date, no report has resulted. There are three phases.
1. Phase 1, launched in July 2009, involves the design and launch of a Web-based questionnaire to assess patient-reported
outcomes and evaluate quality-of-life issues after the laser-assisted eye surgery.
2. Phase 2 will examine quality of life and satisfaction among patients treated at the Navy Refractive Surgery Center
3. Phase 3 will be a national, multi-center clinical trial to study quality of life after Lasik among the general population.
|
|
