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Completed

NCT Number: NCT04333433

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

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Key information

Conditions

Primary Open-Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle Ophtalmologique de la Clinique Mutualiste, Pessac, Bordeaux, France

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About this 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.

Treatment and study plan

PRESERFLO® MicroShunt

Device

Device surgically implanted

Other names: InnFocus MicroShunt® Glaucoma Drainage System

trabeculectomy

Procedure

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.

Primary outcomes

  1. Incidence of Sight-threatening Adverse Events

    Time frame: Month 36 thru Month 60

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

Sponsors and collaborators

Lead sponsor

InnFocus Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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