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Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23.

A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study.

Author information

1
University of Minnesota, Minnesota Eye Consultants, Minneapolis, Minnesota. Electronic address: twsamuelson@mneye.com.
2
Altos Eye Physicians, Los Altos, California.
3
Texan Eye and Keystone Research, Austin, Texas.
4
Ophthalmology Associates, Fort Worth, Texas.
5
Department of Ophthalmology, St. Thomas Hospital, London, United Kingdom.
6
Department of Ophthalmology, University of Toronto, Toronto, Canada.
7
Wilmer Eye Institute, Baltimore, Maryland.
8
Singapore National Eye Center, Singapore.
9
Moran Eye Center, University of Utah, Salt Lake City, Utah.
10
Stanford University, Stanford, California.

Abstract

OBJECTIVE:

To compare cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months.

DESIGN:

Prospective, multicenter, single-masked, randomized controlled trial.

PARTICIPANTS:

Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg.

METHODS:

Subjects were randomized 2:1 to receive a single Hydrus Microstent (Ivantis, Inc, Irvine, CA) in the Schlemm canal or no stent after uncomplicated phacoemulsification. Comprehensive eye examinations were conducted 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months postoperatively. Medication washout and MDIOP measurement were repeated at 12 and 24 months.

MAIN OUTCOME MEASURES:

The primary and secondary effectiveness end points were the proportion of subjects demonstrating a 20% or greater reduction in unmedicated MDIOP and change in mean MDIOP from baseline at 24 months, respectively. Hypotensive medication use was tracked throughout the course of follow-up. Safety measures included the frequency of surgical complications and adverse events.

RESULTS:

A total of 369 eyes were randomized after phacoemulsification to Hydrus Microstent (HMS) and 187 to no microstent (NMS). At 24 months, unmedicated MDIOP was reduced by ≥20% in 77.3% of HMS group eyes and in 57.8% of NMS group eyes (difference = 19.5%, 95% confidence interval [CI] 11.2%-27.8%, P < 0.001). The mean reduction in 24-month unmedicated MDIOP was -7.6±4.1 mmHg (mean ± standard deviation) in the HMS group and -5.3±3.9 mmHg in the NMS group (difference = -2.3 mmHg; 95% CI, -3.0 to -1.6; P < 0.001). The mean number of medications was reduced from 1.7±0.9 at baseline to 0.3±0.8 at 24 months in the HMS group and from 1.7±0.9 to 0.7±0.9 in the NMS group (difference = -0.4 medications; P < 0.001). There were no serious ocular adverse events related to the microstent, and no significant differences in safety parameters between the 2 groups.

CONCLUSIONS:

This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone.

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