Feb. 25, 2010— -- Below is the FDA's response to "Good Morning America's" story about LASIK eye surgery.
What are you doing to look into all the complaints about LASIK?
The FDA is concerned about reports of patient problems post-LASIK. The agency has established and promoted better mechanisms for reporting adverse events, update information on our Web site to better communicate the risks and benefits of this procedure and to better monitor and improve the safety and effectiveness of the lasers used in the LASIK surgery.
In addition, we have taken several steps to try and better understanding the nature of potential problems and how the FDA may help patients, health care providers and manufacturers avoid them.
This year, the FDA issued a letter to LASIK providers outlining issues related to advertising, specifically what may constitute false and misleading advertising regarding LASIK.
The FDA's Office of Compliance inspected a number of LASIK facilities, which revealed inadequate adverse event reporting systems. The agency issued warning letters to errant facilities and will follow up on their remedial actions.
On the regulatory front, the agency has recognized a specific standard, which outlines the testing and clinical studies necessary for the FDA to approve any new lasers used in this surgery.
We have also been hard at work developing our plans for a national study on post-LASIK problems. More details are outlined below.
All of this and more information are updated regularly on the FDA's Web site.
When do you expect to have your studies completed on the "quality of life" issues?
The results from this project will help the FDA identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.
The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant health-related quality of life problems after LASIK surgery and identify predictors of these problems. The Project is composed of three phases. In an effort to maximize time efficiency, FDA is working in collaboration with the Department of Defense and the National Eye Institute on planning and execution of all three phases simultaneously. In Phase 1 of the project, we are developing a new Web-based questionnaire to assess patient-reported outcomes post-LASIK. The electronic format of this questionnaire will be used during Phase 2 and Phase 3.
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.
In its consideration of LASIK applications, the FDA followed the October 10, 1996 guidance entitled "Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers."
Prior to publication of the guidance document, preliminary drafts were discussed extensively at two public meetings of the Ophthalmic Devices Advisory Panel (7/20/1995 and 4/1/1996). Information from these meetings and input from the Eye Care Technology Forum (ECTF) working group, manufacturers, health care professionals, and consumers, was incorporated into FDA's final guidance. (Oct 10, 1996). After publication, proposed expansions of the guidance were discussed at two additional public meetings of the Ophthalmic Devices Panel (10/21/97 and 10/22/1998). These discussions resulted in a broad consensus regarding the definition and acceptable levels of occurrence of adverse events in IDE clinical trials for refractive surgery laser systems. These were utilized in the subsequent reviews of LASIK pre-market submissions.
In addition to an extensive pre-clinical and clinical data review by FDA, for each first-of-a-kind indication for LASIK devices, input was sought from an Ophthalmic Panel.
How satisfied are you that doctors give patients a clear pictures of not just the benefits, but the risks of the surgery?
The FDA firmly believes in patient education.
Each LASIK laser has a patient information booklet that describes the risks associated with that particular laser. In addition, we have strengthened information on our Web site that outlines risks and benefits of LASIK as well as a "checklist" for patients thinking of undergoing the procedures.
However, it is important to remember that the FDA does not regulate the practice of medicine. We regulate the lasers used in the procedure. Thus, while each manufacturer has a patient information booklet, we can not enforce physician distribution of the booklets to all patients.
During the April 2008 panel meeting, we heard concerns from patients regarding the lack of balanced information about LASIK from their eye care providers.
This was one reason we issued a letter to eye care professionals, providing them with important information about the promotion and advertising of FDA-approved lasers used during LASIK. This letter was widely disseminated with the help of the professional organizations.
There's a chart on your website which indicates that "after surgery" many of the side effects disappear in a short time. Data shows that is not true for everyone. Is this chart misleading?
This chart along with the accompanying text is meant to provide patients with a general understanding of what symptoms may be expected postoperatively and when those symptoms are generally expected to wane.
It is not meant to represent the experience of each individual patient, or to replace a discussion between the patient and his or her eye doctor on what symptoms that particular patient should expect and how long those symptoms are expected to last.
We discuss symptoms in the context of risks of surgery in the section of the Web site titled "What are the risks and how can I find the right doctor for me?"
Again, the Web site is meant to help spur dialogue between the patient and his or her doctor.