Clinical trial NCT01881425: InnFocus MicroShunt Versus Trabeculectomy Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: POAG
Lead sponsor: InnFocus Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 732
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
timeFrame: 12 months
measure: Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
timeFrame: 24 months
Secondary outcomes:
measure: Mean Diurnal Intraocular Pressure Change
timeFrame: 12 months
measure: Mean Diurnal Intraocular Pressure Change
timeFrame: 24 months
measure: Number of Participants With Postoperative Interventions at 12 Months
timeFrame: 12 months
measure: Participants With Postoperative Interventions at 24 Months
timeFrame: 24 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Eye Physicians and Surgeons of Arizona
state: Arizona
city: Tucson
country: United States
facility: Arizona Eye Consultants
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Davis
country: United States
facility: University of California at Davis Eye Center
state: California
city: Los Angeles
country: United States
facility: UCLA Jules Stein Eye Institute
state: California
city: Fairfield
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
city: Eagle
country: United States
facility: Inter-Mountain Eye Care
state: Idaho
city: Glenview
country: United States
facility: Chicago Glaucoma Consultants and CGC Eye Center
state: Illinois
city: Indianapolis
country: United States
facility: Eugene and Marilyn Glick Eye Institute
state: Indiana
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence
state: Kansas
city: Chevy Chase
country: United States
facility: Washington Eye Physicians and Surgeons
state: Maryland
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: Omaha
country: United States
facility: Midwest Eye Surgery Center
state: Nebraska
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mt. Sinai
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Ophthalmic Surgeons and Consultants of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Houston
country: United States
facility: The Robert Cizik Eye Clinic
state: Texas
city: San Antonio
country: United States
facility: Rashid, Rice, Flynn and Reilley Eye Associates
state: Texas
city: Bellevue
country: United States
facility: Specialty Eye Care
state: Washington
city: Pessac
country: France
facility: Pole Ophtalmologique de la Clinique Mutualiste
state: Bordeaux
city: Pisa
country: Italy
facility: Pisa University Hospital Cisanello
city: Maastricht
country: Netherlands
facility: University Eye Clinic Maastricht
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Paul Palmberg, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.