InnFocus MicroShunt Versus Trabeculectomy Study



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 85
Updated:8/5/2018
Start Date:August 2013
End Date:November 2019

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A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShuntTM Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

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.

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.

Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and
≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery -
Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any
condition that prevents the device implantation or trabeculectomy in the superior region of
the study eye
We found this trial at
25
sites
Fairfield, Connecticut 06824
Principal Investigator: Robert Noecker, MD
Phone: 203-237-1818
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100 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
Principal Investigator: Marlene Moster, M.D.
Phone: 484-434-2706
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Bala-Cynwyd, PA
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Bellevue, Washington 98004
Principal Investigator: Howard Barneby, MD
Phone: 425-454-3937
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Bloomington, Minnesota 55431
Principal Investigator: Christine Larsen, M.D.
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Chevy Chase, Maryland
Principal Investigator: Kenneth Schwartz, M.D.
Phone: 301-654-5114
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Cincinnati, Ohio 45242
Principal Investigator: Anup Khatana, M.D.
Phone: 513-569-3682
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Columbus, Ohio 43215
Principal Investigator: Doug Baker, M.D.
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Dallas, Texas 75231
Principal Investigator: Davinder Grover, M.D.
Phone: 214-765-9720
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Davis, California 95817
Principal Investigator: Michelle Lim, M.D.
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Davis, CA
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Eagle, Idaho 83616
Principal Investigator: Adam Reynolds, M.D.
Phone: 208-841-8624
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Eagle, ID
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Fayetteville, Arkansas 72704
Principal Investigator: Steven Vold, MD
Phone: 479-442-8653
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Fort Worth, Texas 76102
Principal Investigator: Brian Flowers, M.D.
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Glendale, Arizona 85306
Principal Investigator: George Reiss, M.D.
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Glenview, Illinois 60026
Principal Investigator: Steven Brown, M.D.
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Houston, Texas 77030
Principal Investigator: Robert Feldman, M.D.
Phone: 713-559-5200
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Houston, TX
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Indianapolis, Indiana 46290
Principal Investigator: Louis Cantor, M.D.
Phone: 317-814-2745
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Indianapolis, IN
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Los Angeles, California 90095
Principal Investigator: Joseph Caprioli, M.D.
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Los Angeles, CA
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New York, New York 10003
Principal Investigator: Joseph Panarelli, M.D.
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Oklahoma City, Oklahoma 73104
Principal Investigator: Mahmoud Khaimi, M.D.
Phone: 405-271-6307
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Oklahoma City, OK
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Omaha, Nebraska 68131
Principal Investigator: Martin Mizener, M.D.
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Omaha, NE
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Overland Park, Kansas 66213
Principal Investigator: Michael Stiles, MD
Phone: 913-681-1601
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Overland Park, KS
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46 Avenue du Docteur Albert Schweitzer
Pessac, Bordeaux 33600
Principal Investigator: Isabelle Riss, MD
Phone: 33-6-185-42-752
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San Antonio, Texas 78229
Principal Investigator: William Flynn, M.D.
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Slingerlands, New York 12159
Principal Investigator: Steven Simmons, M.D.
Phone: 518-475-7300
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Slingerlands, NY
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Tucson, Arizona 85710
Principal Investigator: Jason Levine, M.D.
Phone: 520-327-3487
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