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Keep this study
Lead
InnFocus Inc.
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-005 clinical study, by collecting safety data through 5 years post-operative follow-up.
Age
40–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
2. 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).
3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.
You may not be if
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.
Clareo Health | PRESERFLO® MicroShunt Extension Study
