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K. Mansouri, T. Shaarawy, A. Mermoud; Randomised Controlled Clinical Trial Comparing a Rigid Polymethyl-Methacrylate (PMMA) Implant With the Collagen Implant in Non-Penetrating Deep Sclerectomy . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1187.
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Purpose: To compare the intraocular pressure lowering effect and the safety of a new cross-shaped, non-absorbable Polymethyl-Methacrylate (PMMA) implant with the standard collagen implant during deep sclerectomy procedure. Methods: 60 patients with medically uncontrolled primary and secondary open angle glaucoma were randomly assigned to receive either a PMMA implant (30 eyes) or the collagen implant (30 eyes). The patients were examined before and after the operation at 1 day, 1, 2, 3 weeks and 1, 2, 3, 6, 9 and 12 months. At each visit, the following examinations were performed: slit lamp, tonometry, visual acuity and visual field. Results: The mean follow-up period was 11.5 (SD 2.8) months. The mean preoperative IOP was 21.9 (SD 8.9) for the PMMA and 20.9 (SD 7.6) for the collagen implant. The mean post-operative IOP 7.6 (SD 4.7) mm Hg (PMMA) vs. 5.8 (SD 5.8) mm Hg (C) at day 1, 13.9 (SD 3.0) mm Hg (PMMA) vs. 15.2 (SD 2.3) mm Hg (C) at month 9, and 14.1 (SD 3.5) mm Hg (PMMA) vs. 14.9 (SD 5.1) mm Hg (C) at month 12. Complete success rate at 12 months, defined as an IOP lower than 21 without medication, was 54% (PMMA) vs. 59% (Collagen). Qualified success rate, defined as IOP below 21 with or without medication was at 96% (PMMA) vs. 100% (C). There were no significant differences between the two groups in postoperative and transient complications. Conclusions: Deep sclerectomy with the new cross-shaped PMMA implant provides comparable results in efficiency and safety to the collagen implant.
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