Tool provides standard for assessing LASIK patient-reported outcomes

Reviewed by Kerry D. Solomon, MD

With completion of the Patient-Reported Outcomes with LASIK (PROWL) studies, clinicians and researchers will now be able to use a scientifically validated questionnaire to evaluate patient experiences after LASIK.

The tool (http://bit.ly/2viA0rv) is an important advance for enabling accurate and standardized reporting of patient satisfaction, eye-related symptoms, and their effect on daily function and well being, said Kerry D. Solomon, MD.

“Until PROWL, researchers and clinicians used subjective reports to assess outcomes from the patients’ perspectives,” said Dr. Solomon, partner, Carolina Eyecare Physicians, Mount Pleasant, SC, and adjunct clinical professor of ophthalmology, Storm Eye Institute, Medical University of South Carolina, Charleston. “These data are difficult to interpret, however, because patients use different terms to describe their experiences. Furthermore, . . . some patients do not discuss them at all.”

This new questionnaire provides an instrument to systematically collect and reliably capture patient-reported outcomes with LASIK, he noted. Accurate symptom information can help steer clinical practice by guiding good patient selection and facilitating preoperative counseling. The new tool also adds value in collecting meaningful data in future research studies.

Facilitating discussions

Malvina Eydelman, MD, director, Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, FDA Center for Devices and Radiological Health, Rockville, MD, also noted the benefit of a validated questionnaire to document symptoms before/after LASIK and to facilitate patient-surgeon discussions.

“Looking at reports of visual symptoms made by patients to their surgeons, we found that patients were more than twice as likely to report postoperative visual symptoms on the questionnaire than to relay that information to their eye-care provider,” Dr. Eydelman said. “We recommend that practitioners consider using questionnaires to better document their patients’ symptoms before surgery and track the status of their symptoms following surgery.”

Performed within the scope of the LASIK Quality of Life Collaboration Project-a government partnership involving the FDA, National Eye Institute (NEI), and Department of Defense-the PROWL studies comprised two prospective, observational studies of adults undergoing LASIK for myopia, hyperopia, or astigmatism. PROWL-1, conducted at the Navy Refractive Surgery Center, San Diego, CA, enrolled 262 active-duty U.S. Navy personnel. PROWL-2 enrolled 312 civilians across five private practice and academic sites.

Wavefront-guided LASIK represented 45% of procedures in PROWL-1 and 33% of PROWL-2 procedures. With a small number of exceptions, the remaining ablations were performed using a standardized aspheric ablation algorithm. Flap creation was done using a femtosecond laser in all procedures in PROWL-1, and all but 2% of PROWL-2 procedures.

About 90% of participants in each study completed the questionnaire anonymously prior to surgery, of which almost all completed at least one questionnaire postoperatively.

Postoperative data were collected at 1 and 3 months in both studies and also at month 6 in PROWL-1.

The questionnaire included items to assess satisfaction with current vision, satisfaction with LASIK, and the presence, degree of associated bother, and effect on usual activities of four visual symptoms-double images, glare, halos, and starbursts, and dry eye symptom severity. Items from the NEI Refractive Error Quality of Life Instrument, NEI Visual Function Questionnaire, and Ocular Surface Disease Index were also included.

Sastisfaction levels

The PROWL studies were not designed to investigate the safety and efficacy of LASIK, but instead to evaluate the quality of the questionnaire, Dr. Solomon noted.

Overall, 98% of participants in the PROWL studies reported being satisfied with their surgery at their final visit. Visual symptoms were reported at baseline by a large majority of patients in both the PROWL-1 and PROWL-2 cohorts (67% and 73%, respectively), and the prevalence of these symptoms decreased after LASIK.

Dry eye symptoms also decreased. At baseline, 55% of patients in PROWL-1 and 44% in PROWL-2 had normal Ocular Surface Disease Index scores. At the last follow-up visit, those rates increased to 73% and 65%, respectively.

Within the minority subsets of patients who had no visual symptoms at baseline, new symptoms were reported at 6 months in PROWL-1 by 36% and at 3 months in PROWL-2 by 46%. Moderate or severe dry eye symptoms developed in 4% to 6% of patients who had no dry eye symptoms prior to LASIK. For each type of visual symptom, less than 1% of patients experienced difficulties performing their usual activities because of a visual symptom.

It is important to note that patients were evaluating their visual symptoms without having the benefit of an enhancement or with their BCVA.

It is likely that many of the symptoms reported would be improved with an enhancement procedure in the case of night-vision symptoms or with time in the case of dry eye. Regardless, the presence of these symptoms for the most part did not have a negative impact on a patient’s daily function or patient satisfaction, Dr. Solomon said.

“The most important finding for the PROWL study . . . is the new validated questionnaire that will hopefully provide valuable insight in the future and make this already successful procedure even better,” he said.

To better understand which patients are more likely to be dissatisfied postoperatively, a large observational study, including participants with long-term follow-up after LASIK surgery, would be necessary to accurately estimate the prevalence and find useful predictors for these perceptions, Dr. Eydelman said.

Kerry D. Solomon, MD

E: Kerry.Solomon@carolinaeyecare.com

Dr. Solomon is a consultant to, speaker for, and/or receives research support from companies marketing equipment used in LASIK.