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Autoimmune Dysregulation in Pigmentary Glaucoma - NCT00280345-73104(Clinical Trial 136298)



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City:  Oklahoma City
State:  
OK
Zip Code: 73104
Conditions: Pigmentary Glaucoma - Primary Open Angle Glaucoma - Cataract
Purpose: Based on these recent observations and findings in this new animal model of pigmentary glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior chamber may play a possible role in the development of pigmentary glaucoma and possibly primary open-angle glaucoma (POAG) in humans.
Study summary:
Criteria: Patients in the study will be between 18 and 85 years old. To prevent any possibility that previous manipulation of the iris and uveal structures may affect results of the assays, patients with any previous intraocular surgery or laser iridotomies will be excluded. Patients who have undergone laser trabeculoplasty within 90 days of surgery also will be excluded. In the normal controls undergoing cataract surgery, patients with signs of pigment dispersion syndrome or exfoliation syndrome without glaucoma will be excluded from the study. Additional Inclusion Criteria: 1. In the glaucoma patients, visual field and/or optic disc changes characteristic of glaucoma. 2. Ability to comprehend the information describing the clinical study. 3. Ability to provide signed and dated IRB-approved informed consent (ICF) for the study. Exclusion Criteria: 1. Any clinically significant uncontrolled medical condition(s) that might, in the investigators’ opinion, interfere with the assessment. 2. Use of corticosteroids within 3 months prior to surgery. 3. Use of systemic anti-metabolites within 6 weeks prior to surgery. 4. Use of any investigational drug within 4 weeks prior to surgery. Specific to the study eye exclusions: 1. History of non-iatrogenic uveitis or active uveitis. 2. Discernible congenital abnormality of the anterior chamber structures. 3. Neovascular, uveitic, traumatic, or infantile glaucoma. 4. Proliferative or severe non-proliferative diabetic retinopathy.
Study is available at: Dean A. McGee Eye Institute
Oklahoma City, OK 73104
United States
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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