NCT01881425.

Trial name or 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
Methods	Prospective, randomised, controlled, multicentre study
Participants	Inclusion criteria: Primary open angle glaucoma on maximum tolerated glaucoma medications giving IOP of 15‐40 mmHg Age: 40‐85 years 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
Interventions	Intervention: InnFocus MicroShunt Comparator: trabeculectomy 889 enrolled but intervention and comparator numbers not specified
Outcomes	Primary outcome: > 20% decrease in diurnal IOP to 12 months' follow‐up Secondary outcome: Reduction in diurnal IOP from baseline to 12 months' postoperative examination. Clinical follow‐up will be scheduled over the course of the 24‐month study, and examinations will be repeated to monitor eye health. At 1‐ and 2‐year follow‐up, diurnal IOP taken in the morning, mid‐day, and afternoon in the same day will be performed. Annual follow‐up will occur up to 2 years.
Starting date	June 2013
Contact information	Haydee Frost, CCRC. Tel: 305‐378‐2651 ext 246; e‐mail: hfrost@innfocusinc.com
Notes	Funding source: InnFocus Inc.

IOP: intraocular pressure