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PRESERFLO® MicroShunt Extension Study | Clinical Trials | Clareo Health

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COMPLETEDNCT04333433

PRESERFLO® MicroShunt Extension Study

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...

Lead sponsor: InnFocus Inc.•19 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

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 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 22, 2024Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment279

Start dateMay 2020

Last updatedMar 22, 2024

Condition

Primary Open-angle Glaucoma

Locations shown

Arizona Advance Eye Research Institute, LLC.

Glendale, Arizona

Vold Vision

Fayetteville, Arkansas

UCLA Medical Center Jules Stein Eye Institute

Los Angeles, California

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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: May 10, 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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