Status:
COMPLETED
Autoimmune Dysregulation in Pigmentary Glaucoma
Lead Sponsor:
University of Oklahoma
Conditions:
Pigmentary Glaucoma
Primary Open Angle Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 poss...
Detailed Description
The aim is to establish, through tissue and aqueous analysis of patients with pigmentary glaucoma, POAG and normal controls, that markers for anterior chamber autoimmune dysfunction occur in significa...
Eligibility Criteria
Inclusion
- 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
- In the glaucoma patients, visual field and/or optic disc changes characteristic of glaucoma.
- Ability to comprehend the information describing the clinical study.
- Ability to provide signed and dated IRB-approved informed consent (ICF) for the study.
Exclusion
- Any clinically significant uncontrolled medical condition(s) that might, in the investigators' opinion, interfere with the assessment.
- Use of corticosteroids within 3 months prior to surgery.
- Use of systemic anti-metabolites within 6 weeks prior to surgery.
- Use of any investigational drug within 4 weeks prior to surgery.
- Specific to the study eye exclusions:
- History of non-iatrogenic uveitis or active uveitis.
- Discernible congenital abnormality of the anterior chamber structures.
- Neovascular, uveitic, traumatic, or infantile glaucoma.
- Proliferative or severe non-proliferative diabetic retinopathy.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00280345
Start Date
February 1 2006
End Date
May 1 2009
Last Update
December 15 2023
Active Locations (1)
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1
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104