Status:
COMPLETED
PRESERFLO® MicroShunt Extension Study
Lead Sponsor:
InnFocus Inc.
Conditions:
Primary Open-angle Glaucoma
Eligibility:
All Genders
40-85 years
Brief Summary
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (P...
Detailed Description
The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-0...
Eligibility Criteria
Inclusion
- Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
- Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
- Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Exclusion
- 1\. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
Key Trial Info
Start Date :
May 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2022
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04333433
Start Date
May 22 2020
End Date
November 24 2022
Last Update
March 22 2024
Active Locations (23)
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1
Arizona Advance Eye Research Institute, LLC.
Glendale, Arizona, United States, 85306
2
Vold Vision
Fayetteville, Arkansas, United States, 72704
3
UCLA Medical Center Jules Stein Eye Institute
Los Angeles, California, United States, 90095
4
University of California at Davis Eye Center
Sacramento, California, United States, 95817