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Sponsors and Collaborators: |
Indiana University Optonol |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00597181 |
The less invasive nature of the Ex-Press Mini shunt with mitomycin C induces less post-operative inflammation than trabeculectomy with mitomycin c.
Condition | Intervention | Phase |
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Glaucoma |
Procedure: Trabeculectomy with mitomycin c Procedure: Ex-Press mini shunt with mitomycin c |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Clinical Study Comparing the Inflammatory Response of the Ex-Press Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open-Angle Glaucoma |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Trabeculectomy with Mitomycin C 0.2 mg/cc for 2 minutes
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Procedure: Trabeculectomy with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
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2: Active Comparator
Ex-Press mini shunt; Model R50 with mitomycin C 0.2 mg/cc for 2 minutes
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Procedure: Ex-Press mini shunt with mitomycin c
mitomycin c 0.2 mg/cc for 2 minutes
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The purpose of this study is to quantify the degree of post-operative inflammation in eyes which have undergone either trabeculectomy filtering surgery or Ex-Press mini shunt insertion. Early intraocular pressure control and postoperative complications will also be noted.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All subjects must:
Exclusion Criteria:
No subject may:
Contact: Joni S Hoop, CCRC | 317-274-2745 | jhoop@iupui.edu |
Contact: Linda S Morgan, CCRC | 317-274-2745 | lismorga@iupui.edu |
United States, Indiana | |
IU Eye at Carmel | Recruiting |
Indianapolis, Indiana, United States, 46290 | |
Contact: Joni S Hoop, CCRC 317-274-2745 jhoop@iupui.edu | |
Contact: Linda S Morgan, CCRC 317-274-2745 lismorga@iupui.edu | |
Principal Investigator: Louis B Cantor, MD | |
Sub-Investigator: Darrell WuDunn, MD, PhD | |
Sub-Investigator: Yara P Catoira-Boyle, MD |
Principal Investigator: | Louis B Cantor, MD | Indiana University School of Medicine |
Responsible Party: | Indiana University ( Louis B. Cantor, M.D. ) |
Study ID Numbers: | 0710-28 |
Study First Received: | January 7, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00597181 |
Health Authority: | United States: Institutional Review Board |
Inflammatory response |
Glaucoma Eye Diseases Glaucoma, Open-Angle Mitomycin |
Mitomycins Hypertension Ocular Hypertension |
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