Patients report high satisfaction rate in FDA LASIK outcomes questionnaire
Ocular Surgery News U.S. Edition, January 25, 2015
After nearly 2 decades of clinical application in the U.S., LASIK has achieved high success and satisfaction rates. Many surgeons and patients attest to positive visual outcomes from LASIK, and LASIK has seen a recent uptick in patients choosing to undergo the procedure.
Data presented at the American Academy of Ophthalmology meeting in Chicago shed new light on patient-reported LASIK outcomes. Some experts believe the study, performed in response to reports of post-LASIK visual symptoms, speaks to the procedure’s safety and efficacy.
PROWL-1 and PROWL-2, part of the U.S. Food and Drug Administration’s LASIK Quality of Life Collaboration Project presented by Malvina B. Eydelman, MD, showed that overall the prevalence of visual symptoms, such as ghosting, glare, halos and starbursts, did not increase in patients undergoing LASIK.
The U.S. Trends in Refractive Surgery: 2014 ISRS Survey, presented at the AAO meeting by Richard J. Duffey, MD, showed that LASIK began to rebound in 2014 after a decade-long decline that Duffey attributed to the economic recession and publicized reports of poor outcomes and visual symptoms.
Kerry D. Solomon, MD, OSN Refractive Surgery Board Member, described the FDA study results as “very reassuring.”
“This is one of the largest prospective studies of LASIK ever done looking at quality of life,” Solomon said. “We [surgeons] support the idea of looking at prospective analyses of LASIK. We support the idea of looking at new information. It’s good for us, and it’s good for patients. We want to provide patients with good, accurate information so that patients can make good informed decisions.”
Many surgeons expected visual outcomes from the PROWL studies to exceed results of early trials for LASIK, according to Mitchell A. Jackson, MD, OSN Refractive Surgery Board Member.
“Before the onset of the PROWL studies, we already anticipated what the results of these studies were going to be … that the outcomes surpassed the expectations of what we expected anyway,” Jackson said.
Jackson attributed earlier reports of poor visual outcomes and visual symptoms, in part, to poor patient screening and selection.
“LASIK itself was not the problem,” Jackson said. “The problem in the past was being able to detect problem patients. You could do perfect surgery on a potentially problem patient not knowing that they were a problem patient because the technology may not have been up to date. There are a lot more things we can do preoperatively to screen out potentially bad patients for this procedure, even if you do perfect surgery on these patients. That’s a big improvement.”
Duffey, an OSN Refractive Surgery Board Member, said the FDA study reinforced the “predominant feeling” within the refractive surgery community that LASIK was “still a very robust procedure that, if anything, had only gotten better, not worse, over time.”
“The glare, halo and dry eye issues had been continuously addressed to the point where we were actually making huge strides and improvements,” Duffey said. “Some of that was preoperative testing, but some of it was also preoperative evaluations of patients where we intervened with dry eye problems, with ocular surface disease. We even precluded surgery on a greater number of patients because it turned out they were less-than-ideal candidates,” Duffey said.