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Sponsors and Collaborators: |
University of Tennessee Optonol |
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Information provided by: | University of Tennessee |
ClinicalTrials.gov Identifier: | NCT00444080 |
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
Condition | Intervention | Phase |
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Glaucoma |
Procedure: Trabeculectomy Device: Ex-PRESS mini shunt |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma |
Estimated Enrollment: | 120 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control Arm: Active Comparator
Subjects undergoing trabeculectomy with the use of Mitomycin C
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Procedure: Trabeculectomy
Standard trabeculectomy procedure
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Treatment Arm: Experimental
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
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Device: Ex-PRESS mini shunt
Ex-PRESS implantation procedure:
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Note that Optonol is the actual sponsor of the trial. The University of Tennessee placed the information on clinicaltrials.gov.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Haiming Du, MD, PHD | hdu@utmem.edu |
United States, California | |
University of California | Not yet recruiting |
San Francisco, California, United States, 94143-0730 | |
Principal Investigator: Robert L Stamper, MD, PHD | |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Principal Investigator: Mark B Sherwood, MD, PHD | |
United States, Oklahoma | |
Dean A. McGee Eye Institute | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Principal Investigator: Steven R Sarkisian, MD, PHD | |
United States, Pennsylvania | |
Wills EYE Institute | Recruiting |
Philadelphia, Pennsylvania, United States, 19066 | |
Principal Investigator: Marlene R Moster, MD, PHD | |
United States, Tennessee | |
University of Tennessee | Recruiting |
Memphis, Tennessee, United States, 38163 | |
Principal Investigator: Peter A Netland, MD, PHD |
Principal Investigator: | Peter A Netland, MD, PHD | University of Tennessee |
Responsible Party: | University of Tennessee ( Peter Netland, MD, Professor ) |
Study ID Numbers: | XVT-01 |
Study First Received: | March 5, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00444080 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ex-PRESS TRABECULECTOMY |
Anti-Bacterial Agents Glaucoma Eye Diseases |
Glaucoma, Open-Angle Hypertension Ocular Hypertension |
Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension |