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

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Pfeiffer, Norbert and García Feijoo, Julián and Martínez de la Casa, Jose Maria and Larrosa Povés, José Manuel and Fea, Antonio and Lemij, Hans and Gandolfi, Stefano and Schwenn, Oliver and Lorenz, Katrin and Samuelson, Thomas W. (2015) A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma. Opthalmology, 122 (7). pp. 1283-1293. ISSN 0161-6420

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Official URL: http://dx.doi.org/10.1016/j.ophtha.2015.03.031




Abstract

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 = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 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 = 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 (1–2 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.


Item Type:Article
Additional Information:

Originally received: August 20, 2014; Final revision: March 26, 2015; Accepted: March 27, 2015; Available online: May 9, 2015.

Uncontrolled Keywords:Schlemm's canal ; Microstent ; Phacoemulsification ; Intraocular pressure ; Open-angle glaucoma ; Randomized trial ; Cataract surgery
Subjects:Medical sciences > Medicine > Surgery
Medical sciences > Medicine > Ophtalmology
ID Code:42609
Deposited On:04 Jul 2017 11:21
Last Modified:04 Jul 2017 11:21

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