Protective Effect of Phenytoin on Glaucoma
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Glaucoma patients with epileptic disorder,receiving different medication than Phenytoin
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Glaucoma patients with no epileptic disorder.
4 parameters will be evaluated for all groups:
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Best corrected visual acuity
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Optic disc cupping
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visual fields and general perimetric indices
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 glaucoma patients who also suffer from epileptic disorder and receiving chronic oral Phenytoin treatment |
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| 2 glaucoma patients who also suffer from epileptic disorder receiving anti-convulsant treatment other then Phenytoin |
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| 3 glaucoma patients with no epileptic disorder and not receiving anti-convulsant treatment |
Outcome Measures
Primary Outcome Measures
- peripapillary RNFL thickness [immediate]
Secondary Outcome Measures
- corrected pattern standard deviation in perimetric visual field [immediate]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of glaucoma
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chronic treatment with phenytoin for any indication
Exclusion Criteria:
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pregnancy
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visual acuity less then 6/60
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beilinson hospital, Rabin medical center | Petah-Tikva | Israel | 49100 |
Sponsors and Collaborators
- Rabin Medical Center
Investigators
- Study Director: Omer Y Bialer, MD, Rabin medical center, Petah Tikva, Israel
- Study Director: Dan Gaa'ton, MD, Rabin medical center, Petah-Tikva, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
- Ben Simon GJ, Bakalash S, Aloni E, Rosner M. A rat model for acute rise in intraocular pressure: immune modulation as a therapeutic strategy. Am J Ophthalmol. 2006 Jun;141(6):1105-11.
- Chidlow G, Wood JP, Casson RJ. Pharmacological neuroprotection for glaucoma. Drugs. 2007;67(5):725-59. Review.
- Huang D, Swanson EA, Lin CP, Schuman JS, Stinson WG, Chang W, Hee MR, Flotte T, Gregory K, Puliafito CA, et al. Optical coherence tomography. Science. 1991 Nov 22;254(5035):1178-81.
- Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30.
- Willmore LJ. Antiepileptic drugs and neuroprotection: current status and future roles. Epilepsy Behav. 2005 Dec;7 Suppl 3:S25-8. Epub 2005 Oct 18. Review.
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