Status:
COMPLETED
Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Lead Sponsor:
University of Virginia
Conditions:
Glaucoma
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for...
Eligibility Criteria
Inclusion
- Adult subject over the age of 18
- Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
- Subject is a candidate for filtering surgery with intraoperative anti-metabolites
- IOP \> 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
- Subject willing to attend all follow-up evaluations
- Subject willing to sign informed consent.
Exclusion
- Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
- Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
- Subject has history of penetrating keratoplasty (PKP)
- Subject underwent large incision extra capsular cataract extraction
- Subject had cataract phacoemulsification within the last month
- Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
- Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
- Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
- IOP of ≤18mmHg
- Subject participates in any other concurrent ocular investigation.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00444080
Start Date
October 1 2006
End Date
January 1 2012
Last Update
October 14 2020
Active Locations (8)
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1
University of California
San Francisco, California, United States, 94143-0730
2
University of Florida
Gainesville, Florida, United States, 32610
3
Washington University
St Louis, Missouri, United States, 63110
4
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104