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
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