Protective Effect of Phenytoin on Glaucoma
Recruitment status was Not yet recruiting
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
Primary Open Angle Glaucoma
Secondary Open Angle Glaucoma
Normal Tension Glaucoma
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma|
- peripapillary RNFL thickness [ Time Frame: immediate ] [ Designated as safety issue: No ]
- corrected pattern standard deviation in perimetric visual field [ Time Frame: immediate ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739154
|Contact: Omer Y Bialer, MDfirstname.lastname@example.org|
|Contact: Dov Weinberger, MDemail@example.com|
|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|