NCT05198297

Safety and Effectiveness of the Hydrus Microstent

The Hydrus® Microstent for Intraocular Pressure (IOP) Reduction in Mild to Moderate Open-Angle Glaucoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.

Detailed description

Qualified subjects will undergo ocular hypotensive medication washout prior to implantation with the Hydrus Microstent. Following implantation on Day 0, subjects will attend 8 scheduled postoperative visits: Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. A decision to terminate the study was made by the Sponsor arising from challenges with enrollment of the target study population, leading to suspension of enrollment and revision of the follow-up period to 12 months. The total duration of participation for each subject was approximately 13 months including the medication washout prior to implantation. This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

Conditions

• Open Angle Glaucoma
• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma
• Pigmentary Glaucoma

Interventions

Type	Name	Description
DEVICE	Hydrus Microstent	Minimally invasive glaucoma surgery device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
PROCEDURE	Ophthalmic surgery	Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Timeline

• Start date: 2021-12-13
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2022-01-20
• Last updated: 2025-01-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study