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Autoimmune Dysregulation in Pigmentary Glaucoma
This study is not yet open for participant recruitment.
Verified by Dean A. McGee Eye Institute, January 2006
Sponsored by: Dean A. McGee Eye Institute
Information provided by: Dean A. McGee Eye Institute
ClinicalTrials.gov Identifier: NCT00280345
  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.


Condition Intervention
Pigmentary Glaucoma
Primary Open Angle Glaucoma
Cataract
Procedure: Trabeculectomy
Procedure: Trabeculectomy and cataract surgery
Procedure: Cataract surgery

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Autoimmune Dysregulation in Pigmentary Glaucoma

Further study details as provided by Dean A. McGee Eye Institute:

Estimated Enrollment: 40
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280345

Locations
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Dean A. McGee Eye Institute
Investigators
Principal Investigator: Adam C Reynolds, MD Dean A. McGee Eye Institute
  More Information

Study ID Numbers: Pigmentary Glaucoma
Study First Received: January 19, 2006
Last Updated: January 19, 2006
ClinicalTrials.gov Identifier: NCT00280345  
Health Authority: United States: Institutional Review Board

Keywords provided by Dean A. McGee Eye Institute:
pigmentary glaucoma
primary open angle glaucoma
cataract
trabeculectomy
cataract surgery

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Cataract
Glaucoma, Open-Angle
Lens Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 15, 2009