Subject With Primary Open-angle Glaucoma (POAG)
Conditions
Keywords
Open angle, Glaucoma, Surgery, Ocular Hypertension, Eye Diseases
Brief summary
The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Detailed description
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Interventions
DEVICEiStent Supra Stent
Implantation of one iStent Supra Stent through a small temporal clear corneal incision
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with primary open-angle glaucoma (POAG) * Subjects on two topical hypotensive medications
Exclusion criteria
* Traumatic, uveitic, neovascular, or angle closure glaucoma * Fellow eye already enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean diurnal Intraocular Pressure < 18 mmHg at month 12 | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 0-61 months | Rate of ocular adverse events through 61 months * Findings from Intraocular Pressure, best corrected visual acuity, visual field, specular microscopy measurements * Findings from slit-lamp, fundus and gonioscopic examinations |
Countries
Armenia
Outcome results
None listed