Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Glaucoma Clinical Trial

Official title:

A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03639870
• Other study ID #: INFI-106-G2W3 (GC-011)
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.

Description:

This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.

• Phakic or pseudophakic.

• Males or females, 45 years of age or older.

Exclusion Criteria:

• Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.

• Active corneal inflammation or edema.

• Retinal disorders not associated with glaucoma.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Model iS3 three-stent trabecular micro-bypass system
Provided in Arm/Group descriptions.

Locations

Country	Name	City	State
United States	Glaucoma Associates of Tx	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effectiveness endpoint	The change in mean diurnal IOP from baseline at 12 months	Month 12 postoperative