iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications

Not Applicable

Terminated

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

• Registration Number: NCT03478293
• Lead Sponsor: Glaukos Corporation

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

Detailed Description

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Diagnosed with primary open angle glaucoma (POAG)
• Subject on two ocular hypotensive medications

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iStent inject surgery	iStent inject surgery	Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject

Primary Outcome Measures

Name	Time	Method
IOP reduction at 12 and 24 months on same number or fewer medications	12 months and 24 months	IOP reduction at 12 and 24 months on same number or fewer medications

Trial Locations

Locations (1)

Department of Ophthalmology - UNIFESP/ Hospital São Paulo; 🇧🇷 São Paulo, Brazil