Some 45% of patients who had a laser eye surgery called LASIK later reported at least 1 visual symptom 3 months after the procedure, the FDA said yesterday.
The reported problems included difficulty driving at night or in sunshine, starbursts, glare, ghosting, halos and severe dry eye, according to the FDA. The watchdog agency said it once intended to run a 2,500-patient study, but the results from its initial Prowl-1 and Prowl-2 programs indicated that "a very large clinical study would be necessary to more accurately estimate the prevalence and find useful predictors for these patients, because there are so few."
"The FDA is unable to conduct a study of such size, although we are pleased to have our questionnaire available to researchers interested in this area," the agency said. The FDA ran the "LASIK Quality of Life Collaboration Project" along with the National Eye Institute and the U.S. Defense Dept.
Although the Prowl studies found that less than 1% of patients had difficulty with their usual activities after LASIK surgery, they showed that up 35% of patients reported halos after a LASIK procedure, the most common reported problem. Up to 30% who had no dry eye symptoms before the surgery reported dry eye symptoms afterward, according to the FDA.
In the Prowl-1 phase, a questionnaire was given to 262 patients treated at the U.S. Naval Medical Center in San Diego with standardized LASIK procedures. Another 312 patients were given the questionnaire as part of the Prowl-2 investigation of a civilian population,according to the safety bureau.
In July, the FDA denied a petition by former staffer Morris Waxler, who led the FDA team that 1st approved LASIK, seeking to have the approval revoked and initiate a recall.
