Primary Open-Angle Glaucoma
Conditions
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
Interventions
DEVICEStents
Two Trabecular meshwork Micro-Bypass stents into the study eye
PROCEDURELaser
Laser Trabeculoplasty
DEVICELaser Trabeculoplasty
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open angle Glaucoma
Exclusion criteria
* Active corneal inflammation or edema * Choroidal detachment, effusion, choroiditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP reduction | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| % IOP reduction | up to 24 months |
Countries
United States
Outcome results
None listed