OPHTHALMOLOGY/PUBLIC POLICY: LASIK update: Seeking public policy solution

Among the achievements IBM is pointing to in celebration of its centennial year is the discovery of interaction between excimer laser and tissue, and the subsequent development of LASIK (laser-assisted in-situ keratomileusis). At the time of its discovery, eye surgeons were searching for an alternative to a scalpel for the surgery procedure pioneered to correct nearsightedness: A scalpel can permanently weaken the cornea, and requires a long recovery time. The laser’s precision and ability to overcome these other shortcomings quickly made LASIK the most popular form of eye surgery and had a revolutionary impact on ophthalmology.

Thirty years later, the U.S. Food and Drug Administration (FDA) lists 28 different excimer lasers approved for use in the surgery, and LASIK has improved the lives of millions of people with refractive vision errors such as myopia and hyperopia (short- and long-sightedness). But because the surgery is irreversible (the procedure permanently changes the shape of the cornea) and a small percentage of people have suffered negative effects, it has come under fire in recent years.

In April 2008, the FDA convened a public advisory panel of outside experts to hear patient experiences with LASIK and consider how to improve information for patients and physicians about LASIK. As a result, the agency implemented several improvements in its outreach to and communication with the public regarding LASIK. Among these efforts was delivery of a warning letter (see http://1.usa.gov/iDSfVy) to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities. (To see “close-out letters” issued once FDA has verified corrective actions, see http://1.usa.gov/ihdnxr.)

The FDA also issued a letter to eyecare professionals containing details on the promotion and advertising of FDA-approved lasers used during LASIK (see http://1.usa.gov/lxjy23), and invited all interested parties to post comments and concerns in a public docket from Sept. 12, 2008 through Nov. 15, 2010 (see http://1.usa.gov/lKpltQ).

Seeking in-depth understanding

But the most intensive of its efforts is the LASIK Quality of Life Collaboration Project (LQOLCP), a study in which the FDA has partnered with the National Eye Institute and the Department of Defense to examine the potential impact on quality of life from LASIK. The goal of the LQOLCP is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

The first phase of LQOLCP involved the design and implementation of a web-based questionnaire to assess outcomes commonly reported by LASIK patients, but not previously adequately measured. This phase also involves interviews with patients contemplating LASIK as well as patients who have experienced poor outcomes and those who have experienced positive outcomes. Results from these interviews have guided modifications to the questionnaire.

The second phase involves a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), in which U.S. military personnel electing LASIK completed the questionnaire before surgery and at 1, 3 and 6 months after surgery. The third phase of the LQOLCP consists of two clinical studies, called PROWL-2a and PROWL-2b.

PROWL-2a is a national, multi-center clinical study examining the reliability of the questionnaire (developed in Phase I and II of the LQOLCP) in a civilian population. Study participants take the questionnaire prior to LASIK surgery and then take a post-operative questionnaire one month after surgery and again three months after surgery. Clinical information on participants are analyzed along with their questionnaire responses both before and after surgery.

PROWL-2b uses the previously evaluated questionnaire in the civilian population to provide estimates of the prevalence of PROs. Similar to PROWL-2a, PROWL-2b is a national, multi-center clinical study of consumers planning to have LASIK surgery. The participants follow up for at least 6 months after the surgery.

The questionnaire and study protocols are developed by a group of government experts from the collaborating agencies. In addition to specialists from the government partnership, an independent body of subject matter authorities selected from professional organizations review the protocols, including the questionnaire, and make recommendations. This independent body has expertise in study design, statistical analysis, measuring patient-reported outcomes, eye surgery and eye care. Two patient representatives, one with a good outcome and another with a poor outcome following LASIK, are also part of the study protocol review group.

Phase III amid increased heat

The situation heated up On February 25, 2010, when Morris Waxler, former FDA official in charge of approving LASIK devices, stated concerns about the risk of serious side-effects and the original FDA approval process that became the subject of an interview on ABC’s Good Morning America TV show. Nearly a year later, on January 6, 2011, Waxler requested that “the Commissioner of Food and Drugs to withdraw FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.” Waxler alleged that “...the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices...”

Meanwhile, plans were underway to launch the LQOLCP’s third phase, in March 2011, when the partner agencies requested proposals for participation in the project from LASIK surgery sites with the capabilities to perform clinical research (notification of selected sites is anticipated to occur in the summer of 2011).

The LQOLCP aims to help measure patient outcomes following LASIK as well as explore factors that may affect them. The findings from the studies are expected to assist doctors and patients considering LASIK to make more informed decisions about the surgery, potentially leading to better outcomes.