FDA Statement in Response to 'GMA's' Story on LASIK Eye Surgery

Phase 2 will be a clinical study to evaluate health-related quality of life and satisfaction following LASIK as reported by patients in an active duty military population treated at a military refractive surgery center. We hope to confirm the validity of the survey instrument (questionnaire), evaluate the ease of administration of the instrument, and pilot the instrument under the uniform conditions of the military prior to using it in the general population. The protocol for this study has been developed by federal experts in clinical research and has been reviewed and approved by an independent committee comprised of patient representatives and experts in refractive surgery, clinical research, and questionnaire development. The protocol is ready for institutional review board submission. Therefore, enrollment into this study has not yet begun.

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?
We're not sure that the premise of your questions is accurate.

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?
The FDA considers LASIK lasers to be reasonably safe and effective when used as intended.

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?
We disagree that the agency ignored problems with LASIK when it was approved.

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.

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