Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma (POAG)
• Interventions: Device: iStent

• Registration Number: NCT01252849
• Lead Sponsor: Glaukos Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

Detailed Description

Not available

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: 2019-10-08
• Study Completion: 2019-10-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subject 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
First Arm: One iStent, medication	iStent	Device: One iStent, medication
Third Arm: Three iStents, medication	iStent	Device: Three iStent devices, medication
Second Arm: Two iStents, medication	iStent	Device: Two iStent devices, medication

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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