Safety and Effectiveness of the Hydrus Microstent

Stopped early · Not applicable

Conditions studied: Open Angle Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma

In brief

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.

Key facts

Study ID

NCT05198297

Run by

Alcon Research

People needed

33

Starts

2021-12-13

Expected to finish

2024-01-31

Last updated by the study team

2025-01-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Early or moderate glaucomatous optic nerve damage;
• Uncomplicated cataract surgery with well centered posterior chamber IOL greater than or equal to 365 days prior to the screening visit;
• Inadequately controlled IOP;
• Shaffer angle grade III-IV in all four quadrants;
• Age appropriate minimum central endothelial cell density;
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma;
• Requires oral hypotensive medications;
• Shallow or flat anterior chamber;
• Prior glaucoma surgery;
• Ocular hypertension;
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Vold Vision PLLC — Bentonville, Arkansas, United States
• The Eye Clinic of Florida — Zephyrhills, Florida, United States
• Fraser Eye Care Center — Fraser, Michigan, United States
• Cincinnati Eye / Apex Eye — Mason, Ohio, United States
• Eye Centers Of Racine And Kenosha — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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