Results from the United States cohort of the HORIZON trial of a Schlemm canal microstent to reduce intraocular pressure in primary open-angle glaucoma

HORIZON U.S. investigators

Research output: Contribution to journalArticle

Abstract

Purpose: To assess the safety and effectiveness of Schlemm canal stenting for reducing intraocular pressure (IOP) in combination with cataract surgery in the United States cohort of the HORIZON study. Setting: Twenty-six clinical sites in the U.S. Design: Prospective clinical trial. Methods: Eyes with mild to moderate primary open-angle glaucoma (POAG) on 1 to 4 medications, significant cataract, and an unmedicated diurnal IOP between 22 mm Hg and 34 mm Hg after medication washout were randomized 2:1 to receive the Hydrus microstent or no further treatment after successful cataract surgery. Patients were followed for 24 months. Medication washout and diurnal IOP measurements were repeated at 12 months and 24 months. Results: Two hundred nineteen eyes were randomized to microstent implantation and 112 patients to phacoemulsification only. At 24 months, the diurnal IOP was reduced by 20.0% or more in a greater proportion of eyes in the microstent group (78.5% versus 54.5%; P <.001). The mean change in the number of medications was −1.2 ± 0.9 (SD) in the microstent group and −0.8 ± 1.1 in the phaco-only group (P <.001), and 78.5% of eyes and 39.2% of eyes, respectively, were medication free (difference 38.8%; P <.001). Conclusions: Implantation of a Schlemm canal microstent after phacoemulsification significantly reduced diurnal IOP and medication use compared with phacoemulsification only in patients with mild to moderately severe POAG. The combination procedure was equivalent to cataract surgery alone in terms of visual acuity outcomes and the rate of adverse ocular events.

Original languageEnglish (US)
Pages (from-to)1305-1315
Number of pages11
JournalJournal of cataract and refractive surgery
Volume45
Issue number9
DOIs
StatePublished - Sep 2019

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Intraocular Pressure
Cataract
Phacoemulsification
Visual Acuity
Primary Open Angle Glaucoma
Cohort Studies
Clinical Trials
Safety

ASJC Scopus subject areas

  • Surgery
  • Ophthalmology
  • Sensory Systems

Cite this

@article{1ad831fb233e4994a6d8f61a4ca3e489,
title = "Results from the United States cohort of the HORIZON trial of a Schlemm canal microstent to reduce intraocular pressure in primary open-angle glaucoma",
abstract = "Purpose: To assess the safety and effectiveness of Schlemm canal stenting for reducing intraocular pressure (IOP) in combination with cataract surgery in the United States cohort of the HORIZON study. Setting: Twenty-six clinical sites in the U.S. Design: Prospective clinical trial. Methods: Eyes with mild to moderate primary open-angle glaucoma (POAG) on 1 to 4 medications, significant cataract, and an unmedicated diurnal IOP between 22 mm Hg and 34 mm Hg after medication washout were randomized 2:1 to receive the Hydrus microstent or no further treatment after successful cataract surgery. Patients were followed for 24 months. Medication washout and diurnal IOP measurements were repeated at 12 months and 24 months. Results: Two hundred nineteen eyes were randomized to microstent implantation and 112 patients to phacoemulsification only. At 24 months, the diurnal IOP was reduced by 20.0{\%} or more in a greater proportion of eyes in the microstent group (78.5{\%} versus 54.5{\%}; P <.001). The mean change in the number of medications was −1.2 ± 0.9 (SD) in the microstent group and −0.8 ± 1.1 in the phaco-only group (P <.001), and 78.5{\%} of eyes and 39.2{\%} of eyes, respectively, were medication free (difference 38.8{\%}; P <.001). Conclusions: Implantation of a Schlemm canal microstent after phacoemulsification significantly reduced diurnal IOP and medication use compared with phacoemulsification only in patients with mild to moderately severe POAG. The combination procedure was equivalent to cataract surgery alone in terms of visual acuity outcomes and the rate of adverse ocular events.",
author = "{HORIZON U.S. investigators} and Jason Jones and Koch, {Douglas D.} and Steven Vold and Cathleen McCabe and Douglas Rhee and Richard Lewis and Stephen Smith and Nguyen, {Quang H.} and Samuelson, {Thomas W.} and Tom Walters and Robert Marquis and Brian Flowers and Vold, {Steven D.} and Smith, {Stephen E.} and Gary Foster and Greene, {Brennan P.} and Tran, {Dan B.} and Husam Ansari and Kenneth Olander and Neil Atodaria and Mujtaba Qazi and Quang Nguyen and Edward Meier and David Godfrey and Mohammed ElMallah and Jason Levine and Johnson, {C. Stark} and Craven, {E. Randy} and Hawkins, {Richard D.} and William Clifford and Singh, {Inder Paul} and Chu, {Y. Ralph} and Crandall, {Alan C.}",
year = "2019",
month = "9",
doi = "10.1016/j.jcrs.2019.03.024",
language = "English (US)",
volume = "45",
pages = "1305--1315",
journal = "Journal of Cataract and Refractive Surgery",
issn = "0886-3350",
publisher = "Elsevier Inc.",
number = "9",

}

TY - JOUR

T1 - Results from the United States cohort of the HORIZON trial of a Schlemm canal microstent to reduce intraocular pressure in primary open-angle glaucoma

AU - HORIZON U.S. investigators

AU - Jones, Jason

AU - Koch, Douglas D.

AU - Vold, Steven

AU - McCabe, Cathleen

AU - Rhee, Douglas

AU - Lewis, Richard

AU - Smith, Stephen

AU - Nguyen, Quang H.

AU - Samuelson, Thomas W.

AU - Walters, Tom

AU - Marquis, Robert

AU - Flowers, Brian

AU - Vold, Steven D.

AU - Smith, Stephen E.

AU - Foster, Gary

AU - Greene, Brennan P.

AU - Tran, Dan B.

AU - Ansari, Husam

AU - Olander, Kenneth

AU - Atodaria, Neil

AU - Qazi, Mujtaba

AU - Nguyen, Quang

AU - Meier, Edward

AU - Godfrey, David

AU - ElMallah, Mohammed

AU - Levine, Jason

AU - Johnson, C. Stark

AU - Craven, E. Randy

AU - Hawkins, Richard D.

AU - Clifford, William

AU - Singh, Inder Paul

AU - Chu, Y. Ralph

AU - Crandall, Alan C.

PY - 2019/9

Y1 - 2019/9

N2 - Purpose: To assess the safety and effectiveness of Schlemm canal stenting for reducing intraocular pressure (IOP) in combination with cataract surgery in the United States cohort of the HORIZON study. Setting: Twenty-six clinical sites in the U.S. Design: Prospective clinical trial. Methods: Eyes with mild to moderate primary open-angle glaucoma (POAG) on 1 to 4 medications, significant cataract, and an unmedicated diurnal IOP between 22 mm Hg and 34 mm Hg after medication washout were randomized 2:1 to receive the Hydrus microstent or no further treatment after successful cataract surgery. Patients were followed for 24 months. Medication washout and diurnal IOP measurements were repeated at 12 months and 24 months. Results: Two hundred nineteen eyes were randomized to microstent implantation and 112 patients to phacoemulsification only. At 24 months, the diurnal IOP was reduced by 20.0% or more in a greater proportion of eyes in the microstent group (78.5% versus 54.5%; P <.001). The mean change in the number of medications was −1.2 ± 0.9 (SD) in the microstent group and −0.8 ± 1.1 in the phaco-only group (P <.001), and 78.5% of eyes and 39.2% of eyes, respectively, were medication free (difference 38.8%; P <.001). Conclusions: Implantation of a Schlemm canal microstent after phacoemulsification significantly reduced diurnal IOP and medication use compared with phacoemulsification only in patients with mild to moderately severe POAG. The combination procedure was equivalent to cataract surgery alone in terms of visual acuity outcomes and the rate of adverse ocular events.

AB - Purpose: To assess the safety and effectiveness of Schlemm canal stenting for reducing intraocular pressure (IOP) in combination with cataract surgery in the United States cohort of the HORIZON study. Setting: Twenty-six clinical sites in the U.S. Design: Prospective clinical trial. Methods: Eyes with mild to moderate primary open-angle glaucoma (POAG) on 1 to 4 medications, significant cataract, and an unmedicated diurnal IOP between 22 mm Hg and 34 mm Hg after medication washout were randomized 2:1 to receive the Hydrus microstent or no further treatment after successful cataract surgery. Patients were followed for 24 months. Medication washout and diurnal IOP measurements were repeated at 12 months and 24 months. Results: Two hundred nineteen eyes were randomized to microstent implantation and 112 patients to phacoemulsification only. At 24 months, the diurnal IOP was reduced by 20.0% or more in a greater proportion of eyes in the microstent group (78.5% versus 54.5%; P <.001). The mean change in the number of medications was −1.2 ± 0.9 (SD) in the microstent group and −0.8 ± 1.1 in the phaco-only group (P <.001), and 78.5% of eyes and 39.2% of eyes, respectively, were medication free (difference 38.8%; P <.001). Conclusions: Implantation of a Schlemm canal microstent after phacoemulsification significantly reduced diurnal IOP and medication use compared with phacoemulsification only in patients with mild to moderately severe POAG. The combination procedure was equivalent to cataract surgery alone in terms of visual acuity outcomes and the rate of adverse ocular events.

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U2 - 10.1016/j.jcrs.2019.03.024

DO - 10.1016/j.jcrs.2019.03.024

M3 - Article

C2 - 31326225

AN - SCOPUS:85068995119

VL - 45

SP - 1305

EP - 1315

JO - Journal of Cataract and Refractive Surgery

JF - Journal of Cataract and Refractive Surgery

SN - 0886-3350

IS - 9

ER -