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Study: Validated questionnaires should be administered to LASIK patients before and after surgery
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The administration of a validated questionnaire to LASIK participants before and after the procedure can effectively assess symptoms and patient satisfaction and determine if patients experience new symptoms after surgery, according to a study.
Researchers assessed preoperative and postoperative visual symptoms of patients enrolled in the Patient-Reported Outcomes With LASIK (PROWL) studies by analyzing completed self-administered, web-based questionnaires given to participants preoperatively and postoperatively from 1 month to 6 months.
The PROWL-1 study included 262 participants, and the PROWL-2 study included 312 participants. The PROWL-1 study assessed symptoms postoperatively at 1 month and 3 months, while the PROWL-2 study assessed symptoms at 6 months.
The majority of patients were satisfied with the surgery results. The rates of dissatisfaction with surgery ranged from 1% to 2%, and the rates of dissatisfaction with vision ranged from 1% to 4%.
The prevalence of dry eye symptoms and visual symptoms decreased in both studies, but several participants reported new symptoms after surgery. Of those participants who reported no visual symptoms, such as halos, starburst, glare and double images, at baseline, 43% in the PROWL-1 study and 46% in the PROWL-2 study reported a new symptom at 3 months. Among the participants who reported visual symptoms at baseline, 46% in the PROWL-1 study and 34% in the PROWL-2 study reported no visual symptoms at 3 months, according to the study data.
The study authors noted that while visual symptoms were common postoperatively, few participants reported that the symptoms had a substantial impact.
“By making the PROWL questionnaire publicly available, the ophthalmic community will have a tool to conduct further research on LASIK surgery. Administering the questionnaire to patients preoperatively and postoperatively will allow us to more accurately assesses visual and ocular symptoms and satisfaction in clinical trials,” they wrote.
Disclosure: The authors report no relevant financial disclosures.
Perspective
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Gregory D. Parkhurst, MD, FACS
The long-awaited Patient-Reported Outcomes with LASIK (PROWL) studies have been published in JAMA Ophthalmology.
The Refractive Surgery Alliance (RSA) is keenly focused on making the procedure as safe as possible, and we welcome any studies that provide insight into patient perspectives about how they feel about their results.
First, the PROWL studies reaffirm what the RSA has reported in the past, which is that LASIK is safe and effective.
Second, the PROWL studies reported that a small group of patients had new postoperative side effects, including dry eye and visual symptoms such as glare, halo, starburst and ghosting. But, overall, the prevalence of visual symptoms and dry eye decreased after having LASIK and improved over time.
However, the PROWL studies were not designed to investigate side effects or test the safety and efficacy of LASIK.
The goal of the studies was to test whether the questionnaire was scientifically valid. With the publication of the PROWL studies, we now know it is and, interestingly, that patients using the questionnaire more accurately assess their symptoms and their level of satisfaction and put those findings in context of their daily lives in terms of function and well-being.
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Eydelman M, et al. JAMA Ophthalmol. 2016;doi:10.1001/jamaophthalmol.2016.4587.
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