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: NCT01517477
• Lead Sponsor: Glaukos Corporation

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• 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
Second Arm: Two iStents	iStent	Device: Two iStent devices
Third Arm: Three iStents	iStent	Device: Three iStent devices
First Arm: One iStent	iStent	Device: One iStent

Primary Outcome Measures

Name	Time	Method
Mean diurnal intraocular pressure (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