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PRESERFLO® MicroShunt Extension Study | Clinical Trials | Clareo Health

COMPLETED

PRESERFLO® MicroShunt Extension Study

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.

NCT04333433•InnFocus Inc.

View on ClinicalTrials.gov

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

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-005 clinical study, by collecting safety data through 5 years post-operative follow-up.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

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

Vold Vision

Fayetteville, Arkansas, United States

UCLA Medical Center Jules Stein Eye Institute

Los Angeles, California, United States

University of California at Davis Eye Center

Sacramento, California, United States

Ophthalmic Consultants of Connecticut

Meriden, Connecticut, United States

Intermountain Eye Center

Eagle, Idaho, United States

Eugene and Marilyn Glick Eye Institute

Indianapolis, Indiana, United States

Stiles Eye Care Excellence & Glaucoma Institute

Overland Park, Kansas, United States

Minnesota Eye Consultants, PA

Bloomington, Minnesota, United States

New York Eye and Ear Infirmary of Mt. Sinai

New York, New York, United States

Key Dates

Start Date

May 22, 2020

Primary Completion Date

November 24, 2022

Completion Date

November 24, 2022

Last Updated

March 22, 2024

Enrollment

279

ACTUAL participants

Conditions

Primary Open-angle Glaucoma

Interventions

PRESERFLO® MicroShunt

DEVICE

Trabeculectomy

PROCEDURE

Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)

NCT04036214

Primary Open-Angle Glaucoma, Unspecified EyeOcular Hypertension

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COMPLETEDNA

Modified Trabeculectomy With an ESST Versus Conventional SST for Management of Primary Open Angle Glaucoma

NCT03480711

Primary Open-angle Glaucoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PRESERFLO® MicroShunt Extension Study

Inclusion Criteria

Exclusion Criteria

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