Protective Effect of Phenytoin on Glaucoma

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00739154

Enrollment

200

Registered

2008-08-21

Start date

2008-11-30

Completion date

2010-12-31

Last updated

2008-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

glaucoma, Phenytoin, retinal nerve fiber layer, corrected pattern standard deviation, visual acuity, optic disc cupping

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: 1. Best corrected visual acuity 2. Optic disc cupping 3. visual fields and general perimetric indices 4. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of glaucoma * chronic treatment with phenytoin for any indication

Exclusion criteria

* pregnancy * visual acuity less then 6/60

Design outcomes

Primary

Measure	Time frame
peripapillary RNFL thickness	immediate

Secondary

Measure	Time frame
corrected pattern standard deviation in perimetric visual field	immediate

Countries

Israel

Contacts

Primary ContactOmer Y Bialer, MD

omerb2@vlalit.org.il972-39376100

Backup ContactDov Weinberger, MD

dwin@clalit.org.il972-39376101

Outcome results