Protective Effect of Phenytoin on Glaucoma

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00739154
• Other study ID #: 005062
• Secondary ID: non
• Status: Not yet recruiting
• Phase: N/A
• First received: August 20, 2008
• Last updated: August 20, 2008
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2008
• Source: Rabin Medical Center
• Contact: Omer Y Bialer, MD
• Phone: 972-39376100
• Email: omerb2[@]vlalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of glaucoma

• chronic treatment with phenytoin for any indication

Exclusion Criteria:

• pregnancy

• visual acuity less then 6/60

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure
• Glaucoma, Open-Angle
• Low Tension Glaucoma
• Narrow-Angle Glaucomas
• Normal Tension Glaucoma
• Primary Open Angle Glaucoma
• Secondary Open Angle Glaucoma

Locations

Country	Name	City	State
Israel	Beilinson hospital, Rabin medical center	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (16)

Ates O, Cayli SR, Gurses I, Turkoz Y, Tarim O, Cakir CO, Kocak A. Comparative neuroprotective effect of sodium channel blockers after experimental spinal cord injury. J Clin Neurosci. 2007 Jul;14(7):658-65. — View Citation

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. — View Citation

Budenz DL, Chang RT, Huang X, Knighton RW, Tielsch JM. Reproducibility of retinal nerve fiber thickness measurements using the stratus OCT in normal and glaucomatous eyes. Invest Ophthalmol Vis Sci. 2005 Jul;46(7):2440-3. — View Citation

Carpineto P, Ciancaglini M, Zuppardi E, Falconio G, Doronzo E, Mastropasqua L. Reliability of nerve fiber layer thickness measurements using optical coherence tomography in normal and glaucomatous eyes. Ophthalmology. 2003 Jan;110(1):190-5. — View Citation

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

Hains BC, Waxman SG. Neuroprotection by sodium channel blockade with phenytoin in an experimental model of glaucoma. Invest Ophthalmol Vis Sci. 2005 Nov;46(11):4164-9. — View Citation

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. — View Citation

Klein BE, Klein R, Sponsel WE, Franke T, Cantor LB, Martone J, Menage MJ. Prevalence of glaucoma. The Beaver Dam Eye Study. Ophthalmology. 1992 Oct;99(10):1499-504. — View Citation

Leung CK, Chan WM, Chong KK, Yung WH, Tang KT, Woo J, Chan WM, Tse KK. Comparative study of retinal nerve fiber layer measurement by StratusOCT and GDx VCC, I: correlation analysis in glaucoma. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3214-20. — View Citation

Lo AC, Black JA, Waxman SG. Neuroprotection of axons with phenytoin in experimental allergic encephalomyelitis. Neuroreport. 2002 Oct 28;13(15):1909-12. — View Citation

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. — View Citation

Naskar R, Quinto K, Romann I, Schuettauf F, Zurakowski D. Phenytoin blocks retinal ganglion cell death after partial optic nerve crush. Exp Eye Res. 2002 Jun;74(6):747-52. — View Citation

Podos SM, Becker B, Beaty C, Cooper DG. Diphenylhydantoin and cortisol metabolism in glaucoma. Am J Ophthalmol. 1972 Sep;74(3):498-500. — View Citation

Savini G, Bellusci C, Carbonelli M, Zanini M, Carelli V, Sadun AA, Barboni P. Detection and quantification of retinal nerve fiber layer thickness in optic disc edema using stratus OCT. Arch Ophthalmol. 2006 Aug;124(8):1111-7. — View Citation

Williams ZY, Schuman JS, Gamell L, Nemi A, Hertzmark E, Fujimoto JG, Mattox C, Simpson J, Wollstein G. Optical coherence tomography measurement of nerve fiber layer thickness and the likelihood of a visual field defect. Am J Ophthalmol. 2002 Oct;134(4):53 — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peripapillary RNFL thickness		immediate	No
Secondary	corrected pattern standard deviation in perimetric visual field		immediate	No