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R. Tadayoni, C. Creuzot-Garcher, J.-F. Korobelnik, Y. Le Mer, P. Massin, E. Vicaut, A. Gaudric; Internal Limiting Membrane Peeling for Large Macular Holes: A Randomized, Multicentric, and Controlled Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5206.
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To investigate whether internal limiting membrane (ILM) peeling increases the success rate of surgery for idiopathic macular holes (MH) larger than 400 µm
Study Design An interventional, controlled, randomized, multicentric, parallel assignment, open label study. The trial was approved by the local ethic committee, was conducted in compliance with the Declaration of Helsinki and registered at ClinicalTrials.gov (Identifier: NCT00190190). Primary outcome measure: frequency of anatomic closure, assessed by OCT, 3 months after surgery. Main Secondary measurements: ETDRS visual acuity, progression of cataract, and frequency of complications. Enrolment: 80 patients over 18 years old, presenting with a MH > 400 µm, were divided into two parallel groups and followed up for 3 months postoperatively. Intervention for all eyes, surgery comprised pars plana vitrectomy, peeling of any epiretinal membrane, 17% C2F6 gas filling and face-down positioning. For eyes in ILM peeling group, the ILM was also peeled after trypan blue staining.
39 patients were included in the ILM peeling group and 41 in the other group. The average sizes of macular holes in the 2 groups were respectively 573 ± 141 vs. 567 ± 113 µm (p=0.9051), and the closure rates respectively 94.9 % vs. 73.2 % (p=0.0085). Secondary measurements were not significantly different between the 2 groups.
This multicentric randomized study proves that the closure rate of the surgery of MH larger than 400 µm is significantly increased by ILM peeling.
Clinical Trial: :
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