Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

Phase 4

Completed

• Conditions: Subjects With Primary Open-angle Glaucoma (POAG)
• Interventions: Device: iStent

• Registration Number: NCT01252862
• Lead Sponsor: Glaukos Corporation

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Detailed Description

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

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: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosed with primary open-angle glaucoma (POAG)
• Subject on one topical hypotensive medication

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
Two iStents devices	iStent	Two iStents devices will be implanted

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
IOP < 18 mm Hg at Month 12	12 months

Trial Locations

Locations (1)

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