Protective Effect of Phenytoin on Glaucoma
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|ClinicalTrials.gov Identifier: NCT00739154|
Recruitment Status : Unknown
Verified August 2008 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 21, 2008
Last Update Posted : August 21, 2008
since glaucoma is considered an optic neuropathy, new treatments for glaucoma are being continuously investigated, including neuroprotection.
Previous studies implied that phenytoin, a potent anti-convulsive drug, has a neuroprotective role, and Na+ channels blockage was suggested as a possible mechanism.
This study predicts that glaucoma patients taking Phenytoin will have a less advanced glaucoma as compared to patients not taking the drug. Glaucoma severity will be determined by visual acuity, visual fields, optic disc cupping and nerve fiber layer thickness
|Condition or disease|
|Primary Open Angle Glaucoma Secondary Open Angle Glaucoma Narrow-Angle Glaucomas Normal Tension Glaucoma|
The study will examine adult patients who suffer from glaucoma and epileptic disorders on the same time. the study group will include glaucoma patients, being treated with oral Phenytoin for their epileptic disorder. The study group will be compared to 2 control groups:
- Glaucoma patients with epileptic disorder,receiving different medication than Phenytoin
Glaucoma patients with no epileptic disorder.
4 parameters will be evaluated for all groups:
- Best corrected visual acuity
- Optic disc cupping
- visual fields and general perimetric indices
- peripapillary retinal nerve fiber layer.
Every participant in the study,after giving his informed consent, will be evaluated by a senior ophthalmologist in a single office appointment. The appointment will include a visual acuity, complete ophthalmic examination,Humphrey perimetric visual field testing and peripapillary RNFL thickness measurement by OCT.
no drug or other treatment will be given to the participants
after data collection, average +/-Standard deviation for the 4 parameters will be compared between the 3 groups. Student T-test and one- way ANOVA will be used for statistical analysis.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
U.S. FDA Resources
glaucoma patients who also suffer from epileptic disorder and receiving chronic oral Phenytoin treatment
glaucoma patients who also suffer from epileptic disorder receiving anti-convulsant treatment other then Phenytoin
glaucoma patients with no epileptic disorder and not receiving anti-convulsant treatment
- peripapillary RNFL thickness [ Time Frame: immediate ]
- corrected pattern standard deviation in perimetric visual field [ Time Frame: immediate ]
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): NCT00739154
|Contact: Omer Y Bialer, MDemail@example.com|
|Contact: Dov Weinberger, MDfirstname.lastname@example.org|
|Beilinson hospital, Rabin medical center|
|Petah-Tikva, Israel, 49100|
|Study Director:||Omer Y Bialer, MD||Rabin medical center, Petah Tikva, Israel|
|Study Director:||Dan Gaa'ton, MD||Rabin medical center, Petah-Tikva, Israel|