A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent

Phase 4

Completed

• Conditions: Subject With Primary Open-angle Glaucoma (POAG)
• Interventions: Device: iStent Supra Stent

• Registration Number: NCT01252914
• Lead Sponsor: Glaukos Corporation

Brief Summary

The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Detailed Description

The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subjects on two topical hypotensive medications

Exclusion Criteria

• Traumatic, uveitic, neovascular, or angle closure glaucoma
• Fellow eye already enrolled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One iStent Supra Stent and medication	iStent Supra Stent	The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma

Primary Outcome Measures

Name	Time	Method
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline	12 months

Secondary Outcome Measures

Name	Time	Method
Mean diurnal Intraocular Pressure < 18 mmHg at month 12	12 months

Trial Locations

Locations (1)

S.V. Malayan Ophthalmology Centre; 🇦🇲 Yerevan, Armenia