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Protective Effect of Phenytoin on Glaucoma

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Open Angle Glaucoma; Secondary Open Angle Glaucoma; Narrow-Angle Glaucomas; Normal Tension Glaucoma

Phase: N/A

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Omer Y Bialer, MD, Study Director, Affiliation: Rabin medical center, Petah Tikva, Israel
Dan Gaa'ton, MD, Study Director, Affiliation: Rabin medical center, Petah-Tikva, Israel

Overall contact:
Omer Y Bialer, MD, Phone: 972-39376100, Email: omerb2@vlalit.org.il

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional

Primary outcome: peripapillary RNFL thickness

Secondary outcome: corrected pattern standard deviation in perimetric visual field

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of glaucoma

- chronic treatment with phenytoin for any indication

Exclusion Criteria:

- pregnancy

- visual acuity less then 6/60

Locations and Contacts

Omer Y Bialer, MD, Phone: 972-39376100, Email: omerb2@vlalit.org.il

Beilinson hospital, Rabin medical center, Petah-Tikva 49100, Israel
Additional Information

Related publications:

Chidlow G, Wood JP, Casson RJ. Pharmacological neuroprotection for glaucoma. Drugs. 2007;67(5):725-59. Review.

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.

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.

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.

Starting date: November 2008
Last updated: August 20, 2008

Page last updated: August 23, 2015

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