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NCT01461278 Clinical Trial

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

Primary Open-angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01461278
Other study ID # GC-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2011
Est. completion date March 12, 2020

Study information
Verified date May 2022
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 505
Est. completion date March 12, 2020
Est. primary completion date March 13, 2019
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent supra
Cataract surgery and implantation of one iStent supra
Procedure:
• Cataract surgery
Cataract surgery alone

Locations
Country Name City State
United States Eye Centers of Racine and Kenosha Racine Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary = 20% Reduction in Intraocular Pressure (IOP) Baseline and Month 24
Secondary Diurnal IOP Reduction from Baseline Baseline and Month 24
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