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

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 PARTICIPANTS: The 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. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016. MAIN OUTCOMES AND MEASURES: Scales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery). RESULTS: The median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]). CONCLUSIONS AND RELEVANCE: The results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies.

Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.

IMPORTANCE: Patient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery. OBJECTIVE: To report the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies. DESIGN, SETTING, AND PARTICIPANTS: The PROWL-1 and PROWL-2 studies were prospective, observational studies conducted from September 13, 2011, to June 27, 2014. The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel 21 to 52 years of age. The PROWL-2 study was a study of 312 civilians 21 to 57 years of age conducted at 5 private practice and academic centers. The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgment at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (the PROWL-1 and -2 studies) and at 6 months (the PROWL-2 study). EXPOSURES: Participants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism. MAIN OUTCOMES AND MEASURES: Visual symptoms (double images, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with vision and LASIK surgery), and clinical measures (visual acuity, refractive error, and slitlamp and posterior segment eye examination findings) were assessed preoperatively and at 1, 3, and 6 months postoperatively. RESULTS: A total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%). CONCLUSIONS AND RELEVANCE: The systematic administration of a questionnaire to patients who have undergone LASIK surgery is a new approach to assess symptoms and satisfaction. Our findings support the need for adequate counseling about the possibility of developing new symptoms after LASIK surgery.

Web-based versus paper administration of common ophthalmic questionnaires: comparison of subscale scores.

OBJECTIVE: To compare participants' responses to Web-based and paper-and-pencil versions of an ophthalmic, patient-reported outcome (PRO) questionnaire. DESIGN: Questionnaire development. PARTICIPANTS: Matched subjects with ocular surface disease (OSD) (n = 68) and without OSD (controls, n = 50). METHODS: Subjects completed a standard, paper-and-pencil and a Web-based version of the same questionnaire in randomized order. The administered questionnaire included several ophthalmic PRO subscales: the National Eye Institute's (NEI's) Refractive Error Quality of Life Instrument's Clarity of Vision, Near Vision, Far Vision, Glare, Symptoms, Worry, and Satisfaction with Correction subscales; the Ocular Surface Disease Index's (OSDI's) Symptoms subscale; and the NEI's Visual Function Questionnaire's Driving subscale. Possible scores for each subscale ranged from 0 (no difficulty) to 100 (most difficulty). Agreement of subscale scores between modes of administration was assessed using the Bland-Altman approach and multivariable logistic regression. MAIN OUTCOME MEASURES: Subscale scores and an unweighted average total score for each mode of administration. RESULTS: Mean differences in scores between modes of administration ranged from -2.1 to +2.3 units. Although no differences were found to be statistically significant, the Worry and Satisfaction with Correction subscales approached statistical significance (P = 0.07 and 0.08, respectively). Although most subscale mean differences in score did not differ significantly by gender, age (≥40 vs. <40 years), disease status (OSD vs. control), order of administration, or time between completion of the questionnaires, women had slightly greater score differences than men for the Driving (P = 0.04) and Clarity of Vision (P = 0.03) subscales; those with OSD had greater score differences for Clarity of Vision than did controls (P = 0.0006); and those aged ≥40 years had slightly greater differences in OSDI Symptoms subscale than those aged <40 years (P = 0.04). CONCLUSIONS: To our knowledge, this Food and Drug Administration and NEI collaboration is the first study to evaluate the equivalence of Web-based and paper versions of ophthalmic PRO questionnaires. We found no evidence of clinically significant differences between scores obtained by the 2 modes for any of the examined subscales. A Web-based instrument should yield scores equivalent to those obtained by standard methods, providing a useful tool that may facilitate ophthalmic innovation. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Preliminary assessment of celecoxib and microdiode pulse laser treatment of diabetic macular edema.

PURPOSE: Inflammation may play an important role in the pathogenesis of diabetic macular edema, a major cause of vision loss in persons with diabetes. The purpose of this study was to evaluate combined antiinflammatory therapy and laser approaches for treating patients with diabetic macular edema. METHODS: In this prospective, factorial, randomized, multicenter trial, we compared cyclo-oxygenase-2 inhibitor (celecoxib) with placebo and diode grid laser with standard Early Treatment Diabetic Retinopathy Study focal laser treatment in 86 participants with diabetic macular edema. The primary outcome is change in visual acuity of > or = 15 letters from baseline, and the secondary outcomes include a 50% reduction in the retinal thickening of diabetic macular edema measured by optical coherence tomography and a 50% reduction in leakage severity on fluorescein angiography. RESULTS: Visual acuity and retinal thickening data from >2 years of follow-up did not show evidence of differences between the medical and laser treatments. However, participants assigned to the celecoxib group were more likely to have a reduction in fluorescein leakage when compared with the placebo group (odds ratio = 3.6; P < 0.01). CONCLUSION: This short-term study did not find large visual function benefits of treatment with celecoxib or diode laser compared with those of standard laser treatment. A suggestive effect of celecoxib in reducing fluorescein leakage was observed.

Infliximab for the treatment of active scleritis.

OBJECTIVE: This study aimed to evaluate the possible safety and effectiveness of infliximab in patients with active scleritis. STUDY DESIGN: Prospective, nonrandomized, open-label pilot study (Protocol No. 04-EI-0065). PARTICIPANTS: Five patients with active anterior scleritis. METHODS: This single-centre, pilot study of infliximab for the treatment of active anterior scleritis was conducted at the National Eye Institute, National Institutes of Health, between 2003 and 2007. Scleritis patients with active disease who had used at least 1 conventional immunosuppressive agent in the past were included. Primary outcome was a 2-step decrease in scleral inflammation within 14 weeks. Patients received infliximab (5 mg/kg) at baseline, at weeks 2 and 6, and every 4 weeks through week 30, after which the infusion interval was increased (week 36, 48). RESULTS: All patients met the primary outcome by achieving quiescence of their active scleritis by week 14 with no additional immunosuppressives. However, after 14 weeks 1 patient developed new-onset intraocular inflammation that did not respond to reinduction and was terminated from the study. Side effects attributable to infliximab included ear infection with transient decreased hearing, urinary tract infection, lower respiratory tract infection, and facial rash in 1 patient and urinary tract infection, diarrhea, upper respiratory tract infection, nasal congestion and headache, mouth sores, head tremor, and occasional numbness and tingling in extremities in another patient, all of which resolved spontaneously or with appropriate treatment. CONCLUSIONS: Infliximab may be considered as a viable option in treating patients with active scleritis; however, patients should be monitored closely for potentially serious side effects.

Intravitreal ranibizumab therapy for retinal capillary hemangioblastoma related to von Hippel-Lindau disease.

PURPOSE: To evaluate the effect of intravitreal ranibizumab on retinal capillary hemangioblastomas (RCHs) associated with von Hippel-Lindau (VHL) disease that are not amenable or responsive to standard therapy. DESIGN: Prospective, noncomparative, interventional case series. PARTICIPANTS: Five patients with VHL-associated RCH with exudative changes and visual loss. METHODS: Monthly intravitreal injections of ranibizumab (0.5 mg) were given over a course of 6 months for a total of 7 injections, with additional injections considered until week 52. The final study visit was designated as 8 weeks after the final study injection. MAIN OUTCOME MEASURES: The primary outcome was the change in best-corrected visual acuity (BCVA) of >/=15 letters at the final visit compared with baseline. Secondary outcomes included change in lesion size, exudation as assessed clinically and by fluorescein angiography, change in retinal thickness as evaluated by optical coherence tomography, and adverse event assessments. RESULTS: Patients received an average of 10.0+/-3.1 injections over an average period of 47+/-14 weeks, including follow-up. Mean change in BCVA was a decrease of 9+/-20 letters, with 1 patient gaining >/=15 letters, and 2 patients losing >/=15 letters. Changes in both lesion size and exudation were variable. CONCLUSIONS: Intravitreal ranibizumab, delivered as monotherapy every 4 weeks, had minimal beneficial effects on most VHL-related RCHs. Possible treatment efficacy was demonstrated in the patient with the smallest lesion with less exudation. Future prospective studies are needed to determine the potential role of an antiangiogenic agent, possibly in combination with other therapies for the treatment of such advanced ocular tumors associated with VHL.