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D.S. Minckler, G. Baerveldt, M.R. Alfaro, B.A. Francis; Clinical Results of Trabeculectomy AB Interno With the TrabectomeTM for Open Angle Glaucoma . Invest. Ophthalmol. Vis. Sci. 2005;46(13):73.
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Purpose: To describe clinical results from a pilot study of a novel glaucoma surgical device and procedure Methods: This prospective interventional case series involved thirty–seven patients with medically uncontrolled chronic open–angle glaucoma and no prior surgery or laser. Seventeen males and twenty females were included. Thirty–six eyes were phakic and one was pseudophakic. The trabeculectomy ab interno using the Trabectome was performed by four surgeons in one eye of each patient between March 2003 and July 2004. Intraocular pressure control (IOP) and visions were measured before and after surgery using Goldmann applanation tonometry and Snellen charts. Intraoperative and postoperative adverse events were tabulated and the number of preoperative and postoperative adjunctive medications compared before and after surgery. Results: Preoperative IOPs averaged 28.2 + 4.4 mmHg (with one week medication wash out) and 22.6 + 4.7 mmHg (under medication). Three patients had no topical medications due to intolerance or economic limitation. Follow–up ranged between 13 months (n = 5) and 3 months (n = 6). The mean postoperative IOP at one day = 18.4 + 10.9 (n = 37); at one week = 17.5 + 5.9 mmHg (n = 37); at one month = 17.1 + 5.4 mmHg (n = 37); at three months = 17.8 + 4.2 mmHg (n = 20); at six months = 17.1 + 3.7 mmHg (n = 19); at 12 months = 16.2 + 1.9 mmHg (n = 11); and at 13 months = 15.6 + 2.2 mmHg (n = 5). Visions returned to preoperative levels beyond three weeks postoperatively, except in one patient who had a late recurrence of hyphema due to trauma. The number of adjunctive medications decreased from 1.2 + 0.6 among preoperative patients on medications (n = 36) to 0.4 + 0.7 among 19 patients back on antihypertensive medications at six months. Expected intraoperative blood reflux at surgery occurred in all eyes and was present at day one in 22 eyes (59%) with clearing by slit lamp exam at a mean of 6.4 + 4.1 days postoperatively. Conclusions: This pilot study of ab interno trabeculectomy has demonstrated that the TrabectomeTM is a safe and effective device to lower IOP in open–angle glaucoma. A large randomized multi–center clinical trial comparing this new device to trabeculectomy is justified.
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