Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
October 20, 2014
In a long-awaited report on a collaborative study it conducted on the post-surgical quality of life of LASIK patients, FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industry-favored term “visual symptoms” vs. the agency’s former use of the terms “adverse reactions” or “adverse events.” Delivered by CDRH ophthalmic devices chief Malvina Eydelman at a LASIK-friendly forum staged by the American Academy of Ophthalmology (AAO) 10/17 in Chicago and posted on FDA’s Web site 10/20, FDA’s report said “some” patients in the study developed “problems” after surgery like “difficulty driving at night or in sunshine, [that] severely impacted a patient’s daily living, and included debilitating vision symptoms (seeing starbursts, glare, ghosting, or halos) and severe dry eye.” It says nothing about psychiatric problems, depression and suicide linked to adverse LASIK outcomes; its limited scope (three months post-surgery) and small subject base virtually assured it would not reach those associations.
FDA’s collaborators in the study were the National Eye Institute and the Department of Defense (especially the pro-LASIK Naval Medical Center in San Diego which encourages service personnel to undergo LASIK and performs most of the LASIK procedures that ensue). The overall study consisted of two underlying initial studies known as PROWL-1 and PROWL-2 (for Patient Reported Outcomes With LASIK), the former being among military personnel and the latter among patients of five commercial LASIK surgical facilities, one of which, the 20/20 Institute in Indianapolis, received an FDA warning letter during the course of PROWL-2 for failing to disclose LASIK risks and thereby misbranding the laser it used.
FDA’s report listed its main findings as follows:
- Up to 45% of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.
- Participants who developed new visual symptoms after surgery, most often developed halos. Up to 35% of participants with no halos before LASIK had halos three months following surgery.
- Up to 30% of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. (This is consistent with previous studies.)
- Less than 1% of study participants experienced “a lot of” difficulty with or inability to do usual activities without corrective lenses because of their visual symptoms (halos, glare, et al) after LASIK surgery.
- Participants who were not satisfied with the LASIK surgery reported all types of visual symptoms the questionnaire measured (double vision/ghosting, starbursts, glare, and halos).
“The findings from this study will help to refine our current thoughts on the labeling for LASIK devices which will be incorporated into our patient labeling guidance,” the report says. “In addition, we will ensure our Web site reflects these findings to better inform consumers of the potential outcomes following LASIK.”
Commenting on Eydelman’s 10/17 AAO presentation, which closely tracked the report FDA subsequently posted to its Web site, LASIK-injured patient advocate Paula Cofer picked up on her admission that “dissatisfaction and disabling symptoms may occur in a significant number of patients.” In a Web posting on LASIK Newswire, Cofer quoted Eydelman as saying that further analyses should be done to explore “other associations” with [LASIK patient] dissatisfaction, and that additional longitudinal studies should be conducted to “explore the factors associated with and predictors of poor outcomes.”
“Remarkably,” Cofer comments, “six years and many tax-payer dollars later, Eydelman is suggesting ‘further analyses’ and additional studies. LASIK critics say Eydelman is a pawn of the LASIK industry and should be fired, and the FDA should take immediate action to protect the public by withdrawing its approval of LASIK. Although LASIK critics say they feel vindicated by the early reporting on the LASIK study, they doubt anything will change.”