Facedown Positioning Following Surgery for Large Full-Thickness Macular Hole: A Multicenter Randomized Clinical Trial
Abstract
IMPORTANCE: The value of facedown positioning following surgery for large full-thickness macular holes is unknown.
OBJECTIVE: To determine whether advice to position facedown postoperatively improves the outcome for large macular holes.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months' follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract.
INTERVENTIONS: Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days.
MAIN OUTCOMES AND MEASURES: The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25.
RESULTS: A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 185 participants or records.
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