NCT03267134

Hydrus Microstent for Refractory Open-Angle Glaucoma

The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Ivantis, Inc. · 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 in patients with refractory open-angle glaucoma.

Detailed description

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Conditions

• Open-angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Hydrus Microstent	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: 2017-08-01
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2017-08-30
• Last updated: 2026-01-14
• Results posted: 2026-01-14

Locations

20 sites across 5 countries: United States, Colombia, Philippines, Spain, United Kingdom

Regulatory

• FDA-regulated device study