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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Trial Summary
Trial Overview
Inclusion Criteria

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
Specialty Eye Care
Bellevue, Washington 98004
Principal Investigator: Howard Barneby, MD
Phone: 425-454-3937
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mi
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Bellevue, WA
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Ophthalmic Partners of Pennsylvania
100 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
Principal Investigator: Marlene Moster, M.D.
Phone: 484-434-2706
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mi
from
Bala-Cynwyd, PA
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Minnesota Eye Consultants
Bloomington, Minnesota 55431
Principal Investigator: Christine Larsen, M.D.
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mi
from
Bloomington, MN
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Washington Eye Physicians and Surgeons
Chevy Chase, Maryland
Principal Investigator: Kenneth Schwartz, M.D.
Phone: 301-654-5114
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mi
from
Chevy Chase, MD
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Cincinnati Eye Institute
Cincinnati, Ohio 45242
Principal Investigator: Anup Khatana, M.D.
Phone: 513-569-3682
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mi
from
Cincinnati, OH
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Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio 43215
Principal Investigator: Doug Baker, M.D.
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mi
from
Columbus, OH
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Glaucoma Associates of Texas
Dallas, Texas 75231
Principal Investigator: Davinder Grover, M.D.
Phone: 214-765-9720
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mi
from
Dallas, TX
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University of California at Davis Eye Center
Davis, California 95817
Principal Investigator: Michelle Lim, M.D.
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mi
from
Davis, CA
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Inter-Mountain Eye Care
Eagle, Idaho 83616
Principal Investigator: Adam Reynolds, M.D.
Phone: 208-841-8624
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mi
from
Eagle, ID
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Ophthalmic Consultants of Connecticut
Fairfield, Connecticut 06824
Principal Investigator: Robert Noecker, MD
Phone: 203-237-1818
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mi
from
Fairfield, CT
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Vold Vision, PLLC
Fayetteville, Arkansas 72704
Principal Investigator: Steven Vold, MD
Phone: 479-442-8653
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from
Fayetteville, AR
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Ophthalmology Associates
Fort Worth, Texas 76102
Principal Investigator: Brian Flowers, M.D.
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from
Fort Worth, TX
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Eye Physicians and Surgeons of Arizona
Glendale, Arizona 85306
Principal Investigator: George Reiss, M.D.
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from
Glendale, AZ
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Chicago Glaucoma Consultants and CGC Eye Center
Glenview, Illinois 60026
Principal Investigator: Steven Brown, M.D.
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mi
from
Glenview, IL
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Robert Cizik Eye Clinic
Houston, Texas 77030
Principal Investigator: Robert Feldman, M.D.
Phone: 713-559-5200
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mi
from
Houston, TX
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Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana 46290
Principal Investigator: Louis Cantor, M.D.
Phone: 317-814-2745
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mi
from
Indianapolis, IN
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UCLA Jules Stein Eye Institute
Los Angeles, California 90095
Principal Investigator: Joseph Caprioli, M.D.
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from
Los Angeles, CA
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New York Eye and Ear Infirmary of Mt. Sinai
New York, New York 10003
Principal Investigator: Joseph Panarelli, M.D.
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mi
from
New York, NY
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Dean McGee Eye Institute
Oklahoma City, Oklahoma 73104
Principal Investigator: Mahmoud Khaimi, M.D.
Phone: 405-271-6307
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mi
from
Oklahoma City, OK
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Midwest Eye Surgery Center
Omaha, Nebraska 68131
Principal Investigator: Martin Mizener, M.D.
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from
Omaha, NE
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Stiles Eyecare Excellence
Overland Park, Kansas 66213
Principal Investigator: Michael Stiles, MD
Phone: 913-681-1601
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mi
from
Overland Park, KS
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Pole Ophtalmologique de la Clinique Mutualiste
46 Avenue du Docteur Albert Schweitzer
Pessac, Bordeaux 33600
Principal Investigator: Isabelle Riss, MD
Phone: 33-6-185-42-752
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mi
from
Pessac,
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Rashid, Rice, Flynn and Reilley Eye Associates
San Antonio, Texas 78229
Principal Investigator: William Flynn, M.D.
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from
San Antonio, TX
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Glaucoma Consultants of the Capital Region
Slingerlands, New York 12159
Principal Investigator: Steven Simmons, M.D.
Phone: 518-475-7300
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mi
from
Slingerlands, NY
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Arizona Eye Consultants
Tucson, Arizona 85710
Principal Investigator: Jason Levine, M.D.
Phone: 520-327-3487
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from
Tucson, AZ
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