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F. Contini, M. Prati, S. Donati, C. Azzolini; Idiopathic Macular Hole: Multicentric Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2006;47(13):1442.
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the aim of this multicenter, prospective, randomized study was to evaluate the efficacy of the indocyanine green (ICG) staining of inner limitant membrane in macular surgery for the treatment of idiopathic macular hole.
176 patients(>21yrs old), with idiopathic macular hole at II and III Gass stage, occurred within 2 years, were enrolled in 17 different italian centres. Patients were randomized and included in two groups on which we performed macular surgery with the ILM removal (Group I, 56 eyes) and with the ILM removal after ICG staining (Group II, 120 eyes). In Group I (mean age 67 yrs old), 16 eyes (28%) presented stage II macular holes and 40 (72%) stage III; in Group II (mean age 69 yrs), 37 eyes (30%) presented stage II and 83 eyes (70%) stage III. A complete ophthalmology visit was performed at the baseline visit and at each follow up visit with ETDRS visual acuity, fluorescein angiography and OCT. We applied T student as statistical method for analysis.
In Group I mean visual acuity at the baseline visit was 0,76 logMar, at 1 month 0,81 logMar, at 3 months 0,62 and at 6 months 0,63. In Group II mean visual acuity at baseline visit was 1,04 logMar, at 1 month 0,98, at 3 months 0,74 and at 6 months 0,61 LogMar.
Comparison between our two Groups shows that the clinical visual acuity recovery was better on patients treated with simple ILM removal than with a previous ICG staining. During the follow–up that difference was more evident at 1 month; visual acuity at 6 months became the same in both Group. This multicentric clinical trial with its interactive web database showed the possibility to limit bias in surgical procedures and data collection and underlined the potential of the e–ophthalmology on clinical research for access, acceptability, reliability and medical efficacy. The Italian Group of Vitreous and Retina supports this study on the creation of database, on data collection and on data elaboration
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