INN-005 protocol
Research type
Research Study
Full 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
IRAS ID
198265
Contact name
Guy Van de Weyer
Contact email
Sponsor organisation
InnFocus, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
The purpose of the research is to compare the safety and efficacy of glaucoma surgery with the InnFocus MicroShunt Glaucoma Drainage System to standard trabeculectomy. Both operations are being compared in this study to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma in whom the IOP is not controlled adequately when using as many types of eye drops for glaucoma as were tolerated and had an effect on the eye pressure.
This study will use the unlicensed medicinal product Mitosol, a commercialised brand in the U.S.A. for Mytomicin C.REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0472
Date of REC Opinion
29 Apr 2016
REC opinion
Further Information Favourable Opinion