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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 y García Feijoo, Julián y Martínez de la Casa, Jose Maria y Larrosa Povés, José Manuel y Fea, Antonio y Lemij, Hans y Gandolfi, Stefano y Schwenn, Oliver y Lorenz, Katrin y 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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URL Oficial: http://dx.doi.org/10.1016/j.ophtha.2015.03.031


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.

Tipo de documento:Artículo
Información Adicional:

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

Palabras clave:Schlemm's canal ; Microstent ; Phacoemulsification ; Intraocular pressure ; Open-angle glaucoma ; Randomized trial ; Cataract surgery
Materias:Ciencias Biomédicas > Medicina > Cirugía
Ciencias Biomédicas > Medicina > Oftalmología
Código ID:42609
Depositado:04 Jul 2017 11:21
Última Modificación:04 Jul 2017 11:21

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