Autoimmune Dysregulation in Pigmentary Glaucoma
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|ClinicalTrials.gov Identifier: NCT00280345|
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : July 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pigmentary Glaucoma Primary Open Angle Glaucoma Cataract||Procedure: Trabeculectomy Procedure: Trabeculectomy and cataract surgery Procedure: Cataract surgery||Not Applicable|
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 significantly different amounts in patients with these conditions when compared to normal controls. We also will attempt to establish, through proven methodologies of tissue gene expression, that the source of these differences in markers, notably PEDF and IL-18, is from the uveal tissues of the anterior chamber, most importantly the iris and possibly the trabecular meshwork as well.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Autoimmune Dysregulation in Pigmentary Glaucoma|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||May 2009|
- Procedure: Trabeculectomy
A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork
- Procedure: 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
- Procedure: Cataract surgery
Removal of the cataract from the eye
- Autoimmune Dysergulation in Pigmentary Glaucoma [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280345
|United States, Oklahoma|
|Dean A. McGee Eye Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||STEVEN R SARKISIAN, MD||Dean A. McGee Eye Institute|