October 19, 2014
Preliminary results from FDA study of LASIK show significant number of patients experience problems.
Presenting preliminary results of the long-awaited LASIK Quality of Life Study during a keynote lecture at a meeting of the American Academy of Ophthalmology in Chicago on 10/17/2014, ophthalmologist Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and ENT Devices, said that “dissatisfaction and disabling symptoms may occur in a significant number of patients”.
Plans for a study to consider how LASIK impacts patients’ quality of life were initially announced in 2008 around the time of a public meeting of the FDA’s ophthalmic devices advisory committee. The meeting was called in response to growing public criticism of the procedure and widespread reports of serious injuries. Testimony at the meeting from members of the public included reports of life-altering LASIK injuries and stories of LASIK-related suicides. Department of Defense LASIK surgeons and representatives of organized ophthalmology groups strongly defended the surgery.
Although LASIK critics were in favor of re-evaluating LASIK safety, many were incensed at the FDA’s plan to partner with organized ophthalmology groups for a prospective study, accusing the agency of placing the fox in charge of the hen house.
More than a year elapsed with no word on the proposed study. Then in October 2009, the FDA issued a press release announcing plans for a government-funded LASIK Quality of Life Study in collaboration with the National Eye Institute and the US Department of Defense. Mysteriously, military LASIK surgeons had replaced organized ophthalmology groups in the planned 2-part clinical study.
An article in the December, 2009 edition of the Journal of the American Medical Association (JAMA) reported that Steve Schallhorn, MD, Capt, US Navy (Retired) is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective.” LASIK critics accused the agency of trading one embarrassing collaborator with conflicts of interest for another.
As a side note, in January 2011, former FDA branch chief for ophthalmic devices, Morris Waxler, PhD, petitioned the agency to withdraw FDA approval for all LASIK devices and issue a LASIK Public Health Advisory. Waxler had been conducting his own review of LASIK safety, and had concluded that the agency had made a mistake in granting the approval.
Five more years passed after the FDA’s 2009 update on the LASIK study. During the six year wait for the study results, the practice of LASIK continued status quo while LASIK injury reports stacked up at the agency. Currently, there are thousands of LASIK injuries on file with the FDA, although LASIK critics insist most injuries are never reported.
With the LASIK Quality of Life Study finally complete, LASIK critics wait for the manuscript to be published. Meanwhile, they point to data that were reported in Chicago to support their assertion that the procedure does not meet FDA safety requirements and therefore should not be performed.
- Thirty percent of subjects with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery.
- Nearly half (45%) of subjects who had no visual symptoms prior to LASIK reported one or more visual symptoms 3 months after LASIK. These include halos at 35 percent, followed by starbursts at 28 percent, glare at 16 percent, and ghosting at 6 percent.
- Visual symptoms were “very” or “extremely” bothersome in up to 4 percent of subjects.
LASIK critics assert that adverse outcomes are more common than the current study shows, as ‘real world’ outcomes are never as good as those reported in clinical trials. Visual symptoms, which are discounted by the FDA in evaluating LASIK safety, accounted for the majority of dissatisfaction with LASIK.
Ten percent of eyes did not achieve 20/20 vision, although subjects were presumably treated using the “latest technology.” Only 63.1% of subjects in study-1 and 53.5% of subjects in study-2 were “completely satisfied” with their vision at 3 months after LASIK.
The study included only 262 military subjects treated at the US Naval Medical Center San Diego with 6-month follow-up and 312 civilian subjects treated at five clinical sites across the US with 3-month follow-up. LASIK critics point to studies which suggest that LASIK results decline over time and published case reports of sight-threatening late onset complications which indicate that problems may present months or years after seemingly successful LASIK.
Moreover, average nearsightedness of subjects was just 2.5 diopters in study-1 and 3.6 diopters in study-2. Had the investigators included more patients with stronger prescriptions, the outcomes would have been even worse.
In her closing remarks, Eydelman is quoted as saying, “Further analyses are needed to explore other associations with dissatisfaction, and additional longitudinal studies are recommended to explore the factors associated with and predictors of poor outcomes.”
Remarkably, 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.
Sources for this article include:
(1) “FDA program tracks post-LASIK patient-reported outcomes.” Ocular Surgery News. Healio. Web. 17 Oct. 2014.
(2) Krader, Cheryl Guttman. “LASIK Quality of Life Collaboration Project characterizes benefit, burden.” Ophthalmology Times. Modern Medicine. Web. 17 Oct. 2014.
(3) Mike Mitka. “FDA Focuses on Quality-of-Life Issues for Patients Following LASIK Surgery.” JAMA.2009;302(22):2420-2422.
(4) Frederick Ferris, MD. PowerPoint presentation at AAO convention. 19 Oct. 2014.
(5) “LASIK Quality of Life Collaboration Project.” FDA. Web. 20 Oct. 2014.
(6) Larkin, Howard. “FDA Releases LASIK Patient Survey, Warns Of Large Numbers Of Dissatisfied Patients.” EuroTimes. Web. 20 Oct. 2014.
(7) Malvina Eydelman, MD. “LASIK Quality of Life Collaboration Project: Study Results Presented at the Refractive Surgery Subspecialty Day of the American Academy of Ophthalmology (AAO) on October 17, 2014” (PDF) FDA. Web. 21 Oct. 2014