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.

InnFocus MicroShunt Versus Trabeculectomy Study

Primary Open Angle Glaucoma

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.

Glaucoma Surgery

InnFocus MicroShunt

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

The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without
increasing number of glaucoma medications from baseline to 12 months follow-up

The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without
increasing number of glaucoma medications from baseline to 24 months follow-up

Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at
12 months.

Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at
24 months

The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative
intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up
visit.

The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative
intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up
visit.

Eye Physicians and Surgeons of Arizona

Arizona Eye Consultants

Vold Vision

University of California at Davis Eye Center

UCLA Jules Stein Eye Institute

Ophthalmic Consultants of Connecticut

Inter-Mountain Eye Care

Chicago Glaucoma Consultants and CGC Eye Center

Eugene and Marilyn Glick Eye Institute

Stiles Eyecare Excellence

Washington Eye Physicians and Surgeons

Minnesota Eye Consultants, PA

Midwest Eye Surgery Center

New York Eye and Ear Infirmary of Mt. Sinai

Glaucoma Consultants of the Capital Region

Cincinnati Eye Institute

Ophthalmic Surgeons and Consultants of Ohio

Dean McGee Eye Institute

Ophthalmic Partners of Pennsylvania

Glaucoma Associates of Texas

Ophthalmology Associates

The Robert Cizik Eye Clinic

Rashid, Rice, Flynn and Reilley Eye Associates

Specialty Eye Care

Pole Ophtalmologique de la Clinique Mutualiste

Pisa University Hospital Cisanello

University Eye Clinic Maastricht

Hospital Clínico San Carlos

Moorfields Eye Hospital

InnFocus MicroShunt Versus Trabeculectomy Study

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

Locations

Location

Status