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

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01461278
• Collaborator: (none)
• Enrollment: 505
• Location: 1
• Arms: 2
• Actual Duration (Months): 98.7
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Device: iStent supra; Procedure: Cataract surgery	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 505 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 22, 2011
• Actual Primary Completion Date: Mar 13, 2019
• Actual Study Completion Date: Mar 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cataract surgery plus iStent supra	Device: iStent supra; Cataract surgery and implantation of one iStent supra; Procedure: Cataract surgery; Cataract surgery alone
Active Comparator: Cataract surgery	Procedure: Cataract surgery; Cataract surgery alone

Outcome Measures

Primary Outcome Measures

1. ≥ 20% Reduction in Intraocular Pressure (IOP) [Baseline and Month 24]

Secondary Outcome Measures

1. Diurnal IOP Reduction from Baseline [Baseline and Month 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Centers of Racine and Kenosha	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

• Glaukos Corporation

Investigators

• Study Chair: Kerry Stephens, O.D., Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT01461278
• Other Study ID Numbers: GC-007
• First Posted: Oct 28, 2011
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Keywords provided by Glaukos Corporation: Primary open-angle glaucoma; POAG; Cataract surgery; Suprachoroidal space; Suprachoroidal stent; iStent supra
• Additional relevant MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle

Study Results

No Results Posted as of May 19, 2022