Status:
COMPLETED
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
Lead Sponsor:
Glaukos Corporation
Conditions:
Eye Diseases
Glaucoma, Open-Angle
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Detailed Description
Two hundred patients will be enrolled in the study at up to 21 clinical 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 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 2012
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00913029
Start Date
May 1 2009
End Date
September 1 2012
Last Update
May 20 2015
Active Locations (16)
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1
SV Malayan Ophthalmological Center
Yerevan, Armenia
2
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
3
CHU de Lyon Hopital Edouard Herriot
Lyon, France, 69437
4
CHNO des Quinze-Vingts
Paris, France, 75012