Eyeworld

3 EW ASCRS NEWS by Liz Hillman EyeWorld Staff Writer Perspectives on the PROWL study February 2017 interpreting observational conclu- sions for the purpose of a patient- reported outcomes questionnaire, as published by Eydelman et al., and not confuse the purpose or findings with a well-controlled, randomized clinical outcomes trial where we may draw clinical observations. "LASIK is one of the most metic- ulously studied surgical procedures performed. We have a vast body of published clinical data supporting the safety and efficacy of LASIK and evaluating the potential for side effects," Dr. Waring said. "As an observational effort, PROWL is an important contribution to the scientific LASIK literature. We must, however, remain diligent in not over interpreting the results." As such, Dr. Waring cited the re- cently published work of Price et al. as an excellent example of a multi- center, well-controlled, large volume study (n=1,800) reporting superior- ity of LASIK to contact lenses in a 3-year longitudinal trial evaluating patient satisfaction and perceived outcomes. 4 EW References 1. U.S. Food and Drug Administration. LASIK Quality of Life Collaboration Project. www. fda.gov/MedicalDevices/ProductsandMedi- calProcedures/SurgeryandLifeSupport/LASIK/ ucm190291.htm. Accessed 1/17/2017. 2. Eydelman M, et al. Symptoms and satis- faction of patients in the Patient-Reported Outcomes With Laser In Situ Keratomile- usis (PROWL) studies. JAMA Ophthalmol. 2017;135:13–22. 3. Hays RD, et al. Assessment of the psycho- metric properties of a questionnaire assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017;135:3–12. 4. Price MO, et al. Three-year longitudinal survey comparing visual satisfaction with LASIK and contact lenses. Ophthalmology. 2016;123:1659–66. Contact information Donnenfeld: ericdonnenfeld@gmail.com Thompson: vance.thompson@vancethompsonvision.com Waring: georgewaringiv@gmail.com Experts agree findings are overwhelmingly positive for LASIK, but some disagree with paper's discussion of the data E ight years ago the U.S. Food and Drug Adminis- tration (FDA), National Eye Institute, and Department of Defense began research to evaluate LASIK in the context of quality of life and patient satisfac- tion. The main aim of the project was to develop a questionnaire to "determine the percent of patients who develop difficulties perform- ing their usual activities following LASIK, and to identify predictors for those patients." 1 The first Patient-Reported Outcomes With Laser In Situ Ker- atomileusis (PROWL) study enrolled 262 military participants, 242 of whom received LASIK and took a questionnaire preoperatively and at 1 month, 3 months, and 6 months postop. Three hundred and twelve civilian participants were enrolled in PROWL-2, 292 of whom had LASIK and took the questionnaire preop- eratively and at 1 and 3 months postop. These questionnaires as- sessed visual symptoms, dry eye, and patient satisfaction with their vision and their surgery. Most recently, Eydelman et al. published "Symptoms and satisfac- tion of patients in the Patient-Re- ported Outcomes With Laser In Situ Keratomileusis (PROWL) studies." 2 Ultimately, the authors advocated for the use of validated question- naires with LASIK patients. They also think their findings "support the need for adequate counseling about the possibility of developing new symptoms after LASIK surgery." EyeWorld asked some of the na- tion's leading ophthalmologists for their thoughts on the latest paper. "I think the PROWL study pro- vides important new insight into the LASIK procedure," said Eric Donnenfeld, MD, in private practice, Ophthalmic Consultants of Long Island, Garden City, New York. "Utilizing patient-reported data, we are given a snapshot of just how good LASIK is today. While not designed to study outcomes, the results of the study are encouraging and mirror what we see in the larger body of literature. Importantly, patient satisfaction remains extraor- dinarily high—more than 95%." Dr. Donnenfeld pointed out how the research showed an overall reduction in complaints of visual symptoms post-LASIK. Despite these positive findings, however, Dr. Donnenfeld thinks the study authors presented the results in a biased manner. "The discussion did not fol- low the results of the study, which unfortunately led to a confusing interpretation and erroneous re- porting of the data in the media. This overshadows the important work of PROWL, which for the first time, gives us a scientifically valid way to collect patient-reported data about the LASIK experience," he said. "However, I fully agree with the authors' conclusions with regard to careful and thorough patient counseling, and I think what we learn from the systematic collection of patient reports moving forward will potentially give us insights that can improve our patient education efforts." Discussion included among a small subset of study participants— those who reported no symptoms prior to LASIK (PROWL-1: n=75, PROWL-2: n=68)—the development of new visual symptoms post-LASIK (43% PROWL-1 and 46% PROWL-2) and dry eye symptoms. The study authors concluded these factors can result in lower satisfaction with vision and the surgery. Overall, 1% of participants reported dissatisfac- tion with their vision 3 to 6 months postop. Dr. Donnenfeld thinks the results of this study presented a skewed perception of the prevalence of dry eye after LASIK because the follow-up period didn't extend to a year, when many LASIK-induced dry eye symptoms would resolve. "Because the study was an observational rather than a clinical effort, the data related to outcomes isn't all that valuable, which the study authors state as well. The study size is too small, the follow- up period too short, and other appropriate control factors were not in place," Dr. Donnenfeld said. "However, some took liberties in reporting clinical findings, which, in the context of an observational study designed with the goal of validating the patient-reported ques- tionnaire, simply isn't correct." Vance Thompson, MD, in private practice, Vance Thompson Vision, Sioux Falls, South Dakota, said the questionnaire developed in the PROWL studies is "important to better evaluate patients' reporting of visual symptoms and to assess the potential of those symptoms to impact a patient's quality of life after LASIK." The study authors wrote that us- ing a questionnaire, like that which they've made publicly available, in clinical trials to assess LASIK satisfac- tion and visual and ocular symp- toms will ultimately "lead to better outcomes and will provide better information for informed consent to patients considering LASIK surgery." Dr. Thompson said while the PROWL studies were not long term, he thinks the validation of the ques- tionnaire and quality of the results at 3 months postop are positive, even without offering laser enhance- ments for healing-induced refractive error and longer-term treatment of dry eye, which can improve pa- tients' level of satisfaction. "I look forward to the first long- term studies with the PROWL vali- dated questionnaire," Dr. Thompson said. George Waring IV, MD, FACS, associate professor of ophthalmol- ogy, director of refractive surgery, Medical University of South Caro- lina, Charleston, South Carolina, said, "A scientifically validated questionnaire to better identify LASIK candidates and learn more about patient outcomes is a won- derful contribution to our field. As stated by the authors, the intended purpose of the study was to validate a questionnaire, not to report on outcomes. Therefore, as a specialty, we must remain cautious in not over

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