Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL)

Abstract

IMPORTANCE Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.OBJECTIVE To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input. DESIGN, SETTING, AND PARTICIPANTSThe Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1.

Patients' satisfaction and subjective happiness after refractive surgery for myopia

“…As postoperative UDVA is related to the QOL, the improvement in QOL would result in higher satisfaction with LASIK surgery. 6 – 9 When considered together, we speculate that LASIK surgery could contribute to patients’ subjective happiness by improving the QOL.…”

“…Several studies have reported improvements in the QOL of patients after LASIK. 6 – 9 Lazon de la Jara et al reported improvement in the QOL of myopia patients after LASIK using the Institute for Eye Research multidimensional QOL scale for myopia. 7 Their research confirmed that LASIK improved the patients’ adaptability, confidence, and sense of well-being, allowing them to have a more optimistic attitude about their lives and increased perceived QOL after surgery.…”

The 25th Anniversary of Laser Vision Correction in the United States

“…In each of the PROWL studies, less than 1% of patients experienced difficulty performing their usual activities following LASIK surgery due to any one symptom and more than 95% were satisfied with their vision. [59][60][61][62][63] As so few patients experienced debilitating symptoms, the FDA decided with its limited resources not to conduct a larger clinical study to estimate prevalence of complications more accurately or find useful predictors in post-LASIK patients.…”

Ocular Surface Pain: A Narrative Review

“…Chronic ocular surface pain has also been associated with refractive surgery [ 43 ]. Dry eye symptoms are common in the first month post photorefractive keratectomy (PRK) [ 41 ] or laser in-situ keratomileusis (LASIK), typically with resolution over the following months, according to the Patient Reported Outcomes With LASIK (PROWL) study [ 44 ]. In the PROWL-1 study, the mean OSDI of 215 patients was significantly less at the six-month post-op period compared to pre-procedure baseline (8 vs. 14, p < 0.001) [ 44 ].…”

“…Dry eye symptoms are common in the first month post photorefractive keratectomy (PRK) [ 41 ] or laser in-situ keratomileusis (LASIK), typically with resolution over the following months, according to the Patient Reported Outcomes With LASIK (PROWL) study [ 44 ]. In the PROWL-1 study, the mean OSDI of 215 patients was significantly less at the six-month post-op period compared to pre-procedure baseline (8 vs. 14, p < 0.001) [ 44 ]. However, rare cases have been documented of persistent refractory ocular surface pain, light sensitivity, and visual difficulty after surgery, often in the absence of ocular surface signs or other triggers [ 45 , 46 ].…”