LASIK Quality of Life Collaboration Project characterizes benefit, burden

October 17, 2014

Preliminary results from the Patient Reported Outcomes with LASIK-1 (PROWL-1) and PROWL-2 studies show that at 3 months after surgery, more than 95% of patients are seeing 20/20 or better uncorrected binocularly and more than 90% have monocular uncorrected visual acuity of 20/20 or better, said Malvina B. Eydelman, MD.

Chicago-Preliminary results from the Patient Reported Outcomes with LASIK-1 (PROWL-1) and PROWL-2 studies show that at 3 months after surgery, more than 95% of patients are seeing 20/20 or better uncorrected binocularly and more than 90% have monocular uncorrected visual acuity of 20/20 or better, said Malvina B. Eydelman, MD.

On the positive side, safety data showed that overall prevalence of visual symptoms did not increase postoperatively, said Dr. Eydelman during Refractive Subspecialty Day here at the annual meeting of the American Academy of Ophthalmology.

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However, up to 45% of subjects who were symptom-free preoperatively developed at least one symptom by 3 months, 4% said that their visual symptoms without correction were very or extremely bothersome, and in 1% of subjects, visual symptoms caused a lot of difficulty with or resulted in inability to perform usual activities, said Dr. Eydelman, director, division of ophthalmic and ENT devices, FDA Center for Devices and Radiological Health, Silver Spring, MD.

“While the latter percentages are low, given the large number of patients undergoing LASIK annually, they indicate that dissatisfaction and disabling symptoms may occur in a significant number of patients,” she said, commenting on the public health implications of the findings.

 

“Currently we are conducting further data analyses, and the FDA will explore avenues to better inform patients and physicians about LASIK risk,” she said.

PROWL-1 and PROWL-2 represent phases II and III of the LASIK Quality of Life Collaboration Project undertaken as a government partnership involving the FDA, National Eye Institute, and Department of Defense. PROWL-1 was conducted at the Navy Refractive Surgery Center in San Diego, CA, and enrolled 262 active duty military personnel. PROWL-2 included 312 civilian patients operated on at 5 clinical sites across the United Staes. Across the two studies, the enrolled subjects had preoperative SE ranging from –11.6 to +4.1 D.

The subjects who were dissatisfied with their vision included three patients in PROWL-1 and ten patients in PROWL-2. The majority of dissatisfied subjects reported visual symptoms, Dr. Eydelman noted.

“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,” she said.