Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.

Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.

Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.

Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.

Inclusion Criteria: An operable age-related cataract A diagnosis of POAG treated with 1 to 4 hypotensive medications Medicated IOP ≤ 31 mmHg Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg Exclusion Criteria: Congenital or developmental glaucoma Previous argon laser trabeculoplasty Ab-interno or ab-externo device implanted in or through Schlemm's Canal Use of oral hypotensive medication for glaucoma for treatment of fellow eye

Zebardast N, Zheng C, Jampel HD. Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial. Ophthalmology. 2020 Oct;127(10):1303-1310. doi: 10.1016/j.ophtha.2020.01.025. Epub 2020 Jan 23.

Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23.