Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2006-02-28
2009-05-31
Brief Summary
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Detailed Description
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The actual etiology at the cellular level of elevated intraocular pressure and the development of pigmentary glaucoma is not well understood in humans. If anterior chamber immune dysfunction were shown to be an important factor in the development of this disease in humans, which apparently is demonstrated by the DBA/2J mouse, it would lead to an important area of further investigation and possible novel approaches in treating or preventing this disease in humans.
We hypothesize that in patients with pigmentary glaucoma, the amount of PEDF in the aqueous is significantly reduced while IL-18 is significantly elevated when compared to the aqueous of normal controls. In patients with POAG, we hypothesize similar results for PEDF, although significantly less reduction of PEDF when compared to the pigmentary glaucoma patients may be an interesting finding as well. With regard to IL-18, it is possible that amounts would be significantly elevated in the pigmentary glaucoma patients when compared to both normal controls and POAG patients. In view of the results from the DBA/2J mouse model, we hope to determine whether expression of PEDF could be down regulated in the iris and/or trabecular meshwork of pigmentary glaucoma patients when compared to POAG patients and whether IL-18 expression in these tissues could be up regulated in pigmentary glaucoma patients when compared to POAG patients.
Such findings would strongly suggest that anterior chamber immune abnormalities play a role in the etiology of pigmentary glaucoma in humans. It already has been suggested that decreased amounts and expression of PEDF are found in patients with glaucoma and other neurodegenerative diseases of the eye. However, the source of the decreased expression has not been identified. If IL-18 production is elevated in pigmentary glaucoma and is up regulated in the anterior chamber structures of the eye in human patients with the disease, this also would be highly suggestive that localized anterior chamber immune dysfunction plays a role in the development of this disease.
Depending on our findings, additional investigations of autoimmune dysregulation in pigmentary glaucoma (and perhaps other secondary glaucomas) may help determine the predictive value of such markers in identifying whether or not patients with pigment dispersion syndrome develop glaucomatous damage.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Interventions
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Trabeculectomy
A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork
Trabeculectomy and cataract surgery
A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork and the removal of the cataract
Cataract surgery
Removal of the cataract from the eye
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
Yes
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Crystal McAfee, MA-HHSA
Role: STUDY_DIRECTOR
Dean A. McGee Eye Institute
Locations
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Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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Pigmentary Glaucoma
Identifier Type: -
Identifier Source: org_study_id