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Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma - NCT00444080-32610(Clinical Trial 164765)



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City:  Gainesville
State:  
FL
Zip Code: 32610
Conditions: Glaucoma
Purpose: 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 which filtering surgery is indicated
Study summary: Note that Optonol is funding the trial. The University of Tennessee placed the information on clinicaltrials.gov.
Criteria: Inclusion Criteria: - 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 intra-operative anti-metabolites - IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit. - Subject underwent clear corneal phacoemulsification at least 3 months prior to initiation visit - Subject willing to attend all follow-up evaluations - Subject willing to sign informed consent. Exclusion Criteria: - 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 had cataract extraction within the last three months - Subject is a candidate for cataract extraction combined with glaucoma surgery - 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 presents vitreous in the anterior chamber for which vitrectomy is anticipated - IOP of ≤18mmHg - Subject participates in any other concurrent ocular investigation.
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Data Source: ClinicalTrials.gov
Date Processed: February 1, 2010
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