Study Results
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View full resultsBasic Information
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COMPLETED
NA
732 participants
INTERVENTIONAL
2015-12-15
2020-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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InnFocus MicroShunt
InnFocus MicroShunt
InnFocus MicroShunt
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Trabeculectomy
glaucoma surgery to reduce IOP
Glaucoma Surgery
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Interventions
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Glaucoma Surgery
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.
InnFocus MicroShunt
An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Eligibility Criteria
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Inclusion Criteria
40 Years
85 Years
ALL
No
Sponsors
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InnFocus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Palmberg, M.D., Ph.D.
Role: STUDY_DIRECTOR
Bascom Palmer Eye Institute
Locations
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Eye Physicians and Surgeons of Arizona
Glendale, Arizona, United States
Arizona Eye Consultants
Tucson, Arizona, United States
Vold Vision
Fayetteville, Arkansas, United States
University of California at Davis Eye Center
Davis, California, United States
UCLA Jules Stein Eye Institute
Los Angeles, California, United States
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, United States
Inter-Mountain Eye Care
Eagle, Idaho, United States
Chicago Glaucoma Consultants and CGC Eye Center
Glenview, Illinois, United States
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, United States
Stiles Eyecare Excellence
Overland Park, Kansas, United States
Washington Eye Physicians and Surgeons
Chevy Chase, Maryland, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States
Midwest Eye Surgery Center
Omaha, Nebraska, United States
New York Eye and Ear Infirmary of Mt. Sinai
New York, New York, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
The Robert Cizik Eye Clinic
Houston, Texas, United States
Rashid, Rice, Flynn and Reilley Eye Associates
San Antonio, Texas, United States
Specialty Eye Care
Bellevue, Washington, United States
Pole Ophtalmologique de la Clinique Mutualiste
Pessac, Bordeaux, France
Pisa University Hospital Cisanello
Pisa, , Italy
University Eye Clinic Maastricht
Maastricht, , Netherlands
Hospital Clínico San Carlos
Madrid, , Spain
Moorfields Eye Hospital
London, , United Kingdom
Countries
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References
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Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INN005
Identifier Type: -
Identifier Source: org_study_id
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