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

Glaukos

Status: Terminated

Conditions: Primary Open-Angle Glaucoma

Treatments: Device: Stents; Device: Laser Trabeculoplasty; Procedure: Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327312

GC-004

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open angle Glaucoma

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Surgical

Experimental group

Description:

Implantation of two Trabecular Meshwork stents into the study eye

Treatment:

Device: Stents

Laser

Active Comparator group

Description:

Laser Trabeculoplasty

Treatment:

Device: Laser Trabeculoplasty

Procedure: Laser