Peter Stalmans, M.D., Ph viagra .D., Matthew S. Benz, M.D., Arnd Gandorfer, M.D., Anselm Kampik, M.D., Aniz Girach, M.D., Stephen Pakola, M.D., and Julia A. Haller, M.D. For the MIVI-TRUST Study Group: Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes The human vitreous body is bounded posteriorly by the retina and is variably adherent to it. Collagen fibrils forming the posterior vitreous cortex are attached at the macula firmly, the central portion of the retina where visual acuity is best, and are linked to its inner limiting membrane by means of a biochemical glue composed of proteoglycans, including fibrinectin and laminin.1-4 With ageing, the gel-like vitreous progressively liquefies and vitreoretinal adhesions weaken, resulting in separation of the vitreous from the retina, or posterior vitreous detachment.5-7 Vitreomacular adhesion is observed following partial posterior vitreous detachment, whenever a part of the posterior vitreous remains mounted on the macula.
Two interim analyses of progression-free of charge survival had been performed when 50 percent and 75 percent of the anticipated events had occurred. The ultimate analysis was arranged at an alpha level of 0.02 so the one-sided cumulative alpha level was 0.025 or the two-sided alpha level was 0.05. All tests were two-sided, therefore the P worth for the final analysis of the principal outcome had to be 0.04 or less to point statistical significance. We estimated that with an example of 690 sufferers and an expected median progression-free survival of 10 months in group 1 and 13 a few months in group 2, the trial could have 90 percent overall capacity to show a between-group difference in the principal final result.