FDA QOL Study

FDA LASIK QOL Study Results*

“The problems some study participants developed after having LASIK surgery, such as difficulty driving at night, severely impacted a patient’s daily living, and included debilitating vision symptoms (seeing starbursts, glare, ghosting, or halos) and severe dry eye. In each of the PROWL studies, less than 1 percent of patients experienced difficulty performing their usual activities following LASIK surgery due to any one symptom.

When LQOLP was designed, we intended to conduct a larger study to identify predictors for those patients who develop difficulties performing their usual activities following LASIK. Given our findings of so few patients experiencing debilitating symptoms, a very large clinical study would be necessary to more accurately estimate the prevalence and find useful predictors for these patients. Although we are pleased to have our questionnaire available to researchers interested in this area, resource limitations prevent the FDA from conducting a study of this size.

Based on further analyses of our studies:

  • Up to 46 percent 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 40 percent of participants with no halos before LASIK had halos three months following surgery.
  • Up to 28 percent 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 percent of study participants experienced “a lot of difficulty” with or inability to do usual activities without corrective lenses because of their visual symptoms (starbursts, double images, halos, glare) after LASIK surgery.
  • More than 95% of participants were satisfied with their vision following LASIK surgery.
  • Participants were more than twice as likely to report their visual symptoms on a questionnaire than to tell them to their health care provider

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. In addition, we will ensure our website reflects these findings to better inform consumers of the potential outcomes following LASIK.”

The complete study information can be found on the FDA site here.

*Barbara Berney, president of Vision Surgery Rehab Network, NFP, served on the steering committee for the study as a patient representative.