739154
Last Update Posted: 2008-08-21
Recruiting status is unknown
All Genders accepted | 18 Years + |
200 Estimated Participants | No Expanded Access |
Observational Study | Does not accept healthy volunteers |
Protective Effect of Phenytoin on Glaucoma
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
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.
Eligibility
Relevant conditions:
Primary Open Angle Glaucoma
Secondary Open Angle Glaucoma
Narrow-Angle Glaucomas
Normal Tension Glaucoma
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
Omer Y Bialer, MD
omerb2@vlalit.org.il
972-39376100
Dov Weinberger, MD
dwin@clalit.org.il
972-39376101
Data sourced from ClinicalTrials.gov