NCT01461278

Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed description

This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Conditions

• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
DEVICE	iStent supra	Cataract surgery and implantation of one iStent supra
PROCEDURE	Cataract surgery	Cataract surgery alone

Timeline

• Start date: 2011-12-22
• Primary completion: 2019-03-13
• Completion: 2020-03-12
• First posted: 2011-10-28
• Last updated: 2022-05-19

Locations

1 site across 1 country: United States