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PRESERFLO® MicroShunt Extension Study

NCT04333433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 279

Last updated 2024-03-22

Study results available
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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.

Conditions

  • Primary Open-angle Glaucoma

Interventions

DEVICE

PRESERFLO® MicroShunt

Device surgically implanted

PROCEDURE

Trabeculectomy

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.

Sponsors & Collaborators

  • InnFocus Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Palmberg, MD, PhD · Bascolm Palmer Eye Institute

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2022-11-24
Completion
2022-11-24
FDA Device
Yes

Countries

  • United States
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333433 on ClinicalTrials.gov