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InnFocus MicroShunt Versus Trabeculectomy Study — IMS  

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Clinical Trial Summary

Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

Clinical Trial Description

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01881425
Study type Interventional
Source InnFocus Inc.
Contact
Status Completed
Phase N/A
Start date December 15, 2015
Completion date January 15, 2020
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