Phase 3 will be a national, multi-center clinical study to determine the percentage of patients in a general LASIK population with significant symptoms and functional limitations after LASIK surgery, as well as explore possible contributing factors to poor outcomes. The protocol for Phase 3 is under development; therefore, enrollment into this study has not yet begun.
The Project is expected to be completed in 2012.
The numbers show that 95% of patients do get some improvement in their vision -- 5% do not -- and many people report problems such as halo's, starbursts, glare, etc. Is 5% non-improvement rate too high for a surgery used by nearly a million people a year?
It is important to make a distinction between patient reported outcomes and objective measurements of vision. You may be referring to patient reported outcomes (PROs) in your question. Based upon our review of the available data, LASIK PROs (including symptoms such as glare and haloes) have not been evaluated in a consistent, scientific manner.
Therefore, although we believe that the percentage of subjects with significant health-related quality-of-life issues is extremely small based on the available data, we cannot make scientifically sound general conclusions at this time.
This is one of the reasons we have launched the LASIK Quality of Life Collaboration Project to improve the way patient reported outcomes are measured and to determine the percentage of patients with significant health-related quality-of-life problems after LASIK surgery.
What is the FDA's current position on the safety of LASIK surgery?
Outcomes of the studies to support approval of the LASIK lasers can be found in the Summary of Safety and Effectiveness Data (SSED) for each approval through the following link found on the LASIK Web site: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm192109.htm.
Former FDA official Morris Waxler has expressed concern that the agency (including he himself) may've ignored too many of the problems with LASIK when it was approved. What is your response to that?
Data submitted to the FDA by manufacturers of each of the currently approved LASIK devices, showed that their benefits outweigh the risks when used as intended in accordance with the approved indications and directions for use.