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A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma

2015; Elsevier BV; Volume: 122; Issue: 7 Linguagem: Inglês

10.1016/j.ophtha.2015.03.031

1549-4713

Norbert Pfeiffer, J. García–Sánchez, J.M. Martínez-de-la-Casa, José M. Larrosa, Antonio Maria Fea, Hans G. Lemij, Stefano Gandolfi, Oliver Schwenn, Katrin Lorenz, Thomas W. Samuelson,

Ophthalmology and Eye Disorders

Purpose: To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG).Design: Prospective, multicenter, randomized, single-masked, controlled clinical trial.Participants: One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. Methods:On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone.Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months.Washout of hypotensive medications was repeated at 12 and 24 months.Main Outcome Measures: Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline.Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed.Safety measures included change in visual acuity, slit-lamp observations, and adverse events. Results:The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P ¼ 0.0008).Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.93.3 mmHg vs. 19.24.7 mmHg; P ¼ 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P ¼ 0.0008).There were no differences in follow-up visual acuity between groups.The only notable device-related adverse event was focal peripheral anterior synechiae (1e2 mm in length).Otherwise, adverse event frequency was similar in the 2 groups.Conclusions: Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.