Glaucoma, Eye Diseases, Glaucoma, Open-Angle
Conditions
Keywords
primary open angle glaucoma (POAG), OAG, glaucoma
Brief summary
Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.
Detailed description
One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.
Interventions
DEVICEiStent
Glaukos iStent, medication
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
No
Inclusion criteria
* Diagnosis of primary open-angle glaucoma * Male or female at least 18 years of age and able to provide written informed consent * Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg * Likely to be available and willing to attend follow-up visits
Exclusion criteria
* Angle closure glaucoma * Secondary glaucomas * Prior glaucoma procedures * Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP 18 mm Hg or less without medications | At 6 months |
| IOP 18 mm Hg or less with or without medications | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean IOP | 12 months |
Countries
Armenia, Austria, France, Germany, Italy, Spain
Outcome results
None listed