Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma - NCT00444080-38163 (Clinical Trial 164768)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy164768.aspx
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| City: |
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Memphis |
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State:
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TN |
| Zip Code: |
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38163 |
| Conditions: |
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Glaucoma |
| Purpose: |
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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
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| Study summary: |
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Note that Optonol is funding the trial. The University of Tennessee placed the information
on clinicaltrials.gov. |
| Criteria: |
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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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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 1, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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