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Randomized Controlled Trial Multicenter Study
Pilot randomised controlled trial of face-down positioning following macular hole surgery.
- C A K Lange, L Membrey, N Ahmad, L Wickham, R E Maclaren, L Solebo, W Xing, C Bunce, E Ezra, D Charteris, B Aylward, D Yorston, Z Gregor, H Zambarakji, and J W Bainbridge.
- Moorfields Eye Hospital, London, UK.
- Eye (Lond). 2012 Feb 1; 26 (2): 272-7.
ObjectiveThis was a pilot randomised controlled trial (RCT) to investigate the effect of post-operative face-down positioning on the outcome of macular hole surgery and to inform the design of a larger definitive study.MethodsIn all, 30 phakic eyes of 30 subjects with idiopathic full-thickness macular holes underwent vitrectomy with dye-assisted peeling of the ILM and 14% perfluoropropane gas. Subjects were randomly allocated to posture face down for 10 days (posturing group) or to avoid a face-up position only (non-posturing group). The primary outcome was anatomical hole closure.ResultsMacular holes closed in 14 of 15 eyes (93.3%; 95% confidence interval (CI) 68-100%) in the posturing group and in 9 of 15 (60%; 95% CI 32-84%) in the non-posturing group. In a subgroup analysis of outcome according to macular hole size, all holes smaller than 400 μm closed regardless of posturing (100%). In contrast, holes larger than 400 μm closed in 10 of 11 eyes (91%; 95% CI 58-99%) in the posturing group and in only 4 of 10 eyes (40%; 95% CI 12-74%) in the non-posturing group (Fisher's exact test P=0.02).ConclusionPost-operative face-down positioning may improve the likelihood of macular hole closure, particularly for holes larger than 400 μm. These results support the case for a RCT.
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