Protective Effect of Phenytoin on Glaucoma

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma

Conditions
-----------------
Primary Open Angle Glaucoma, Secondary Open Angle Glaucoma, Narrow-Angle Glaucomas, Normal Tension Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of glaucoma chronic treatment with phenytoin for any indication Exclusion Criteria: pregnancy visual acuity less then 6/60

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>glaucoma patients who also suffer from epileptic disorder and receiving chronic oral Phenytoin treatment | |
| 2<br>glaucoma patients who also suffer from epileptic disorder receiving anti-convulsant treatment other then Phenytoin | |
| 3<br>glaucoma patients with no epileptic disorder and not receiving anti-convulsant treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripapillary RNFL thickness |  | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected pattern standard deviation in perimetric visual field |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, Phenytoin, retinal nerve fiber layer, corrected pattern standard deviation, visual acuity, optic disc cupping