By: Malvina Eydelman, MD
LASIK (laser-assisted in situ keratomileusis) eye surgery is an alternative for patients who need glasses or contacts to see well. Some 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and a very high number of those patients are satisfied with their surgical outcomes.
However, some patients develop unwanted visual symptoms following surgery, symptoms that can have a significant impact on their daily lives. Patients who see starbursts, glare, ghosting, or halos—or those who experience severe dry eye—may have their daily lives change in negative ways.
While there are risks with all medical procedures – and the risks associated with LASIK are well known – FDA teamed up with the National Institutes of Health (NIH), and the Department of Defense (DoD) to more fully capture the patient experience with LASIK. Through the LQOLCP (LASIK Quality of Life Collaboration Project) and the Patient-Reported Outcomes with LASIK (PROWL) studies, we have developed a valid web-based questionnaire that can be used to assess LASIK patients before and after surgery. The questionnaire is available on FDA’s website.
The new scientifically validated questions can help assess patient expectations, symptoms, and satisfaction, and includes definitions of the visual symptoms and images depicting the range of the symptom to facilitate patients’ reporting. These questions can be used for a variety of purposes, such as being used by eye care providers to monitor symptoms before and after LASIK surgery. Additionally, manufacturers may wish to include such information in future LASIK product submissions along with other clinical and nonclinical evidence for FDA’s benefit-risk determination.
The LQOLCP focused on patient-reported outcomes (PROs)—which are reports of the status of a patient’s health condition that come directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. Using well-developed PRO measures, everyone can better understand the impact that visual symptoms associated with LASIK treatment have on the patient’s life.
The newly-developed questions in the PROWL questionnaire can facilitate discussions between eye care providers and patients considering LASIK surgery. In the PROWL studies, patients were more than twice as likely to report their visual symptoms when filling out a questionnaire, than to tell them to their health care provider.
With this improved collection tool of patient experiences, the development of debilitating symptoms was uncommon. Less than 1 percent of study participants experienced difficulties performing their usual activities following LASIK surgery due to any one symptom in each of the PROWL studies. The PROWL questionnaire can be used in future research to more accurately estimate the prevalence of visual symptoms in LASIK patients and identify the predictors of visual symptoms and dissatisfaction.
By listening to the patient’s perspective during the development, evaluation, and use of medical devices, FDA and manufacturers can work together to better assure that LASIK devices marketed in the United States are safe, effective and meet the needs of the patients for whom they are intended. The patient perspective is so important to us that it is one of FDA’s Center for Devices and Radiological Health’s strategic priorities.
Read more information about the LASIK Quality of Life Collaboration Project.
Malvina Eydelman, M.D., is the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health