Safety and Effectiveness of the Hydrus Microstent
Megadott ok: Enrollment
Key facts
- Where
- Bentonville, Fraser, Kenosha, Mason és Zephyrhills, Egyesült ÁllamokSee the 5 sites
Where in Egyesült Államok
- Vold Vision PLLCBentonville, Egyesült ÁllamokNo longer taking part
- Fraser Eye Care CenterFraser, Egyesült ÁllamokNo longer taking part
- Eye Centers of Racine and KenoshaKenosha, Egyesült ÁllamokNo longer taking part
- Cincinnati Eye / Apex EyeMason, Egyesült ÁllamokNo longer taking part
- The Eye Clinic of FloridaZephyrhills, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Alcon Research
- Trial code
- NCT05198297
- Record updated
- 2025. január 15.
- Original description
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.Read full original descriptionShow less
The Hydrus® Microstent for Intraocular Pressure (IOP) Reduction in Mild to Moderate Open-Angle Glaucoma
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.
Inclusion: 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: Requires oral hypotensive medications; Prior glaucoma surgery; Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma; Ocular hypertension; Shallow or flat anterior chamber; Other protocol-defined exclusion criteria may apply.