NCT04333433

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 279 (actual)
• Sponsor: InnFocus Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: —

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.

Conditions

• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-22
• Primary completion: 2022-11-24
• Completion: 2022-11-24
• First posted: 2020-04-03
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

23 sites across 5 countries: United States, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study