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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- InnFocus Inc.
- Enrollment
- 732
- Locations
- 29
- Primary Endpoint
- Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
InnFocus MicroShunt
InnFocus MicroShunt
Intervention: InnFocus MicroShunt (Device)
Trabeculectomy
glaucoma surgery to reduce IOP
Intervention: Glaucoma Surgery (Procedure)
Outcomes
Primary Outcomes
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
Time Frame: 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
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
Time Frame: 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
Secondary Outcomes
- Number of Participants With Postoperative Interventions at 12 Months(12 months)
- Participants With Postoperative Interventions at 24 Months(24 months)
- Mean Diurnal Intraocular Pressure Change(24 months)
- Mean Diurnal Intraocular Pressure Change(12 months)