FDA Outlines ‘Secret’ LASIK Study Details

Reprinted with permission from www.fdaweb.com

A year after announcing a study to determine the percentage of LASIK laser vision-correction patients with significant quality of life problems after having the surgery and to identify predictors of these problems, FDA 10/19 provided an update on its plans for the three-part study that will run until the end of 2012. Details of the study have been kept under wraps, with numerous requests for information practically being ignored by the agency.

The study was originally announced presumably to quell growing criticism of FDA’s oversight of LASIK’s promotion and usage, and mounting complaints by injured LASIK patients (see earlier story). On the day it announced the study, the agency also issued Warning Letters to 17 LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate systems for reporting adverse events related to the vision correction surgery. It has provided no information on follow-ups, if any, to those letters.

FDA says that in the first part of its study, a Web-based questionnaire was designed and developed “to evaluate patient-reported outcomes that could impact quality of life after LASIK surgery, some of which may be related to the safety of the lasers used in this procedure. The second phase involves a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), where U.S. military personnel electing LASIK will complete the questionnaire preoperatively (before surgery) and at one, three, and six months postoperatively (after surgery). Enrollment for PROWL-1 is slated to begin within the next three months.” This study portion will be conducted at the Naval Medical Center San Diego, where it has conducted more than 50 clinical trials and published 28 papers on refractive surgery. The final phase of the project, the PROWL-2 study, will be a national, multicenter clinical study with a protocol based on the experience from PROWL-1, according to the agency.

Activist members of various injured LASIK patient networks allege that the Naval Medical Center San Diego is staffed by ophthalmic surgeons who are biased in favor of the LASIK procedure, some of whom have testified positively on it at various forums, including a 2008 FDA Ophthalmic Devices Panel meeting which took public testimony from LASIK patients. Commenting on FDA’s update, Florida-based injured patients spokesman Dean Kantis said: “Nothing new here, just the same old stuff. Navy overseeing (fixed studies) and continued non-involvement by the hurt advocates. So they can continue to dupe everybody (but us, of course). We are the enemy, and we’re working for free, right? If it wasn’t corrupt, why not involve us?”

The current study update could be seen as the agency becoming more comfortable with its obligations to be more transparent. Up until now, details of this study have been kept practically secret. Innumerable requests from FDA Webview since March for the names and affiliations of its principal researchers and for a copy of its protocol have gone unanswered by FDA’s Press Office.

Meanwhile, former CDRH chief of ophthalmic devices Morris Waxler has been waging a public awareness battle to discredit the device’s approval under his watch (see story). Most recently, Waxler appeared on CNN to challenge the safety and effectiveness of the LASIK procedure. The segment opened with Waxler saying LASIK’s approval was mistaken because his review team focused on making sure there was no loss of visual acuity from the procedure and did not pay enough attention to other problems like post-procedure glare, halos and night driving problems. His examination of post-approval FDA experience reports showed that only 60% of patients were able to get rid of the glasses and contact lenses — this, plus the level of adverse events, demonstrated to him that LASIK is “a failure.”