TerminatedNot Applicable

Safety and Effectiveness of the Hydrus Microstent

Stopped: Enrollment

United States33 participantsStarted 2021-12-13

Plain-language 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.

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception

Timeframe: Baseline, Month 12 postoperative

Trial details

NCT IDNCT05198297

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More Open Angle Glaucoma trials