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

Glaukos

Status: Completed

Conditions: Primary Open-angle Glaucoma

Treatments: Procedure: Cataract surgery; Device: iStent supra

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461278

GC-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 505 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate open-angle glaucoma
• Characteristics consistent with mild to moderate glaucoma
• Use of one (1) to three (3) medications at time of screening exam

Exclusion criteria

• Pigmentary or pseudoexfoliative glaucoma
• Prior incisional glaucoma surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

505 participants in 2 patient groups

Cataract surgery plus iStent supra

Experimental group

Treatment:

Device: iStent supra

Procedure: Cataract surgery

Cataract surgery

Active Comparator group

Treatment:

Procedure: Cataract surgery