Status:
TERMINATED
Safety and Effectiveness of the Hydrus Microstent
Lead Sponsor:
Alcon Research
Conditions:
Open Angle Glaucoma
Primary Open Angle Glaucoma
Eligibility:
All Genders
45+ years
Phase:
NA
Brief 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 n...
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 ...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05198297
Start Date
December 13 2021
End Date
January 31 2024
Last Update
January 15 2025
Active Locations (5)
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1
Vold Vision PLLC
Bentonville, Arkansas, United States, 72712
2
The Eye Clinic of Florida
Zephyrhills, Florida, United States, 33542
3
Fraser Eye Care Center
Fraser, Michigan, United States, 48026
4
Cincinnati Eye / Apex Eye
Mason, Ohio, United States, 45040