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    Tool provides standard for assessing LASIK patient-reported outcomes

    New questionnaire adds insight into satisfaction, eye-related symptoms, daily function

    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

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