Status:
COMPLETED
InnFocus MicroShunt Versus Trabeculectomy Study
Lead Sponsor:
InnFocus Inc.
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using max...
Detailed Description
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health,...
Eligibility Criteria
Inclusion
- POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg -
Exclusion
- Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
Key Trial Info
Start Date :
December 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2020
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT01881425
Start Date
December 15 2015
End Date
January 15 2020
Last Update
October 26 2022
Active Locations (29)
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1
Eye Physicians and Surgeons of Arizona
Glendale, Arizona, United States, 85306
2
Arizona Eye Consultants
Tucson, Arizona, United States, 85710
3
Vold Vision
Fayetteville, Arkansas, United States, 72704
4
University of California at Davis Eye Center
Davis, California, United States, 95817