Status:
COMPLETED
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Lead Sponsor:
Glaukos Corporation
Conditions:
Glaucoma
Eye Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Detailed Description
One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00911924
Start Date
May 1 2009
End Date
September 1 2013
Last Update
May 20 2015
Active Locations (13)
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1
S.V. Malayan's Ophtalmology Centre
Yerevan, Armenia, 375108
2
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
3
Chu de Lyon Hospital Edouard Herriot
Lyon, France, 69437
4
CHNO des Quinze-Vingts
Paris, France, 75012