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. (C) 2015 by the American Academy of Ophthalmology.

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

FEA, Antonio Maria;
2015

Abstract

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. (C) 2015 by the American Academy of Ophthalmology.
OPHTHALMOLOGY
122
7
1283
1293
www.elsevier.com/locate/ophtha
Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Female; Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Lens Implantation, Intraocular; Limbus Corneae; Male; Middle Aged; Prospective Studies; Prosthesis Implantation; Single-Blind Method; Tonometry, Ocular; Visual Acuity; Visual Fields; Young Adult; Glaucoma Drainage Implants; Phacoemulsification; Stents; Ophthalmology; Medicine (all)
Pfeiffer, Norbert; Garcia-Feijoo, Julian; Martinez-De-La-Casa, Jose M.; Larrosa, Jose M.; Fea, Antonio; Lemij, Hans; Gandolfi, Stefano; Schwenn, Oliver; Lorenz, Katrin; Samuelson, Thomas W.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2318/1569528
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