PRESERFLO® MicroShunt Extension Study

Study Overview
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Brief Summary
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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 (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

Detailed Description
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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.

Official Title
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A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.

Conditions
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Primary Open-angle Glaucoma

Intervention / Treatment
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* Device: PRESERFLO® MicroShunt
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MicroShunt treatment group<br>Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device | Device: PRESERFLO® MicroShunt<br>* Device surgically implanted<br>* Other names: InnFocus MicroShunt® Glaucoma Drainage System;|
| Trabeculectomy control arm<br>Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure | Procedure: Trabeculectomy<br>* The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sight-threatening adverse events | Incidence of sight-threatening adverse events, including but are not limited to events such as endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection | Through 5 years postoperative follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POAG