PRESERFLO® MicroShunt Extension Study

InnFocus Inc.279 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

279

Conditions

Primary Open-angle Glaucoma

Interventions

PRESERFLO® MicroShuntDEVICE

Device surgically implanted

TrabeculectomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. 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.

Locations (23)

Arizona Advance Eye Research Institute, LLC.

Glendale, Arizona, United States

Outcomes

Primary Outcomes

Incidence of Sight-threatening Adverse Events

Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.

Time frame: Month 36 thru Month 60

Data from ClinicalTrials.gov

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