InnFocus MicroShunt Versus Trabeculectomy Study

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma

• 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.

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Study Start: 2015-12-15
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Results First Submitted: 2022-07-11
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Results First Posted: 2022-10-26
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 732

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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