Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

Not Applicable

Terminated

• Conditions: Primary Open-Angle Glaucoma
• Interventions: Procedure: Laser; Device: Stents; Device: Laser Trabeculoplasty

• Registration Number: NCT02327312
• Lead Sponsor: Glaukos Corporation

Brief Summary

To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-06
• Study Start: 2014-12-16
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-30
• Primary Completion: 2019-05-31
• Study Completion: 2020-08-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Open angle Glaucoma

Exclusion Criteria

• Active corneal inflammation or edema
• Choroidal detachment, effusion, choroiditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser	Laser Trabeculoplasty
Laser	Laser Trabeculoplasty	Laser Trabeculoplasty
Surgical	Stents	Implantation of two Trabecular Meshwork stents into the study eye

Primary Outcome Measures

Name	Time	Method
IOP reduction	up to 24 months

Secondary Outcome Measures

Name	Time	Method
% IOP reduction	up to 24 months