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K. Mansouri, V. Tran, A. Mermoud, A. Mermoud; Standard Deep Sclerectomy with Collagen Implant Compared to a New Method of Very Deep Sclerectomy: A Randomised Controlled Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):1054.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To compare the IOP lowering effect and safety of an innovative method of deep sclerectomy (DS), called very deep sclerectomy (VDS) with collagen implant to conventional DS with collagen implant. Methods: The trial involved 50 patients with medically uncontrolled POAG who were randomised to undergo either VDS (25 eyes) or DS (25 eyes). Results: The mean follow–up was 8.1 months (SD 3.1, VDS) and 8.3 months (SD 4.2, DS). The mean post–operative IOP was 5.5 (SD 3.1, VDS) and 7.4 (SD 3.8, DS) at day one and 15.5 (SD 5.7, VDS) and 14.8 (SD 6.1, DS) at the last follow–up. The difference was not statistically significant.Two patients had perforations of the TDM and were excluded from the analysis. Complete Success rate using Kaplan–Meier Survival Analysis was 58 % (VDS) and 61% (DS). The complication rate was comparable in both groups. Conclusions: There were no statistically significant differences after a 8 month follow–up. However, UBM findings showed subchoroidal hyperechotic spaces that could indicate the creation of new uveal pathways in the VDS method.
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