InnFocus MicroShunt Versus Trabeculectomy Study
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Device: InnFocus MicroShuntProcedure: Glaucoma Surgery
- Registration Number
- NCT01881425
- Lead Sponsor
- InnFocus Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 732
- POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg -
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description InnFocus MicroShunt InnFocus MicroShunt InnFocus MicroShunt Trabeculectomy Glaucoma Surgery glaucoma surgery to reduce IOP
- Primary Outcome Measures
Name Time Method Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure 12 months The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure 24 months 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 Outcome Measures
Name Time Method Mean Diurnal Intraocular Pressure Change 24 months Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months
Number of Participants With Postoperative Interventions at 12 Months 12 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.
Participants With Postoperative Interventions at 24 Months 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 24 follow-up visit.
Trial Locations
- Locations (29)
UCLA Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
The Robert Cizik Eye Clinic
🇺🇸Houston, Texas, United States
Rashid, Rice, Flynn and Reilley Eye Associates
🇺🇸San Antonio, Texas, United States
Eugene and Marilyn Glick Eye Institute
🇺🇸Indianapolis, Indiana, United States
Stiles Eyecare Excellence
🇺🇸Overland Park, Kansas, United States
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
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
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
Washington Eye Physicians and Surgeons
🇺🇸Chevy Chase, Maryland, United States
Minnesota Eye Consultants, PA
🇺🇸Bloomington, Minnesota, United States
Glaucoma Consultants of the Capital Region
🇺🇸Slingerlands, New York, 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
Ophthalmic Surgeons and Consultants of Ohio
🇺🇸Columbus, Ohio, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, 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
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
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States