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Status unknownNCT00739154Updated Aug 21, 2008

Protective Effect of Phenytoin on Glaucoma

An observational study in Primary Open Angle Glaucoma, Secondary Open Angle Glaucoma and Narrow-Angle Glaucomas, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-21.

Sponsored by Rabin Medical Center · Observational

The sponsor has not verified this record recently (last verified Aug 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Primary Open Angle Glaucoma
  • Secondary Open Angle Glaucoma
  • Narrow-Angle Glaucomas
  • Normal Tension Glaucoma

Keywords

  • glaucoma
  • Phenytoin
  • retinal nerve fiber layer
  • corrected pattern standard deviation
  • visual acuity
  • optic disc cupping
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 200 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients of a tertiary hospital's specialized epilepsy clinic

Inclusion criteria

  • Clinical diagnosis of glaucoma
  • chronic treatment with phenytoin for any indication

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • visual acuity less then 6/60
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)

Groups and cohorts

  • 1

    glaucoma patients who also suffer from epileptic disorder and receiving chronic oral Phenytoin treatment

  • 2

    glaucoma patients who also suffer from epileptic disorder receiving anti-convulsant treatment other then Phenytoin

  • 3

    glaucoma patients with no epileptic disorder and not receiving anti-convulsant treatment

06

What researchers measure

Primary outcomes

  1. peripapillary RNFL thickness

    Time frame: immediate

Secondary outcomes

  1. corrected pattern standard deviation in perimetric visual field

    Time frame: immediate

07

Study locations

1 site
  • Beilinson hospital, Rabin medical center
    Petah-Tikva, 49100, Israel
08

References and documents

Publications

  • Chidlow G, Wood JP, Casson RJ. Pharmacological neuroprotection for glaucoma. Drugs. 2007;67(5):725-59. doi: 10.2165/00003495-200767050-00006. PubMed 17385943 ↗
  • 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. doi: 10.1016/j.ajo.2006.01.073. PubMed 16765680 ↗
  • Willmore LJ. Antiepileptic drugs and neuroprotection: current status and future roles. Epilepsy Behav. 2005 Dec;7 Suppl 3:S25-8. doi: 10.1016/j.yebeh.2005.08.006. Epub 2005 Oct 18. PubMed 16239127 ↗
  • 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. doi: 10.1126/science.1957169. PubMed 1957169 ↗
  • 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. doi: 10.1016/j.ajo.2005.07.044. PubMed 16386972 ↗
  • 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. doi: 10.1016/s0161-6420(92)31774-9. PubMed 1454314 ↗
  • 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. doi: 10.1016/j.jocn.2006.03.023. PubMed 17532502 ↗
  • Podos SM, Becker B, Beaty C, Cooper DG. Diphenylhydantoin and cortisol metabolism in glaucoma. Am J Ophthalmol. 1972 Sep;74(3):498-500. doi: 10.1016/0002-9394(72)90915-4. No abstract available. PubMed 5053695 ↗
  • 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. doi: 10.1006/exer.2002.1173. PubMed 12126947 ↗
  • Lo AC, Black JA, Waxman SG. Neuroprotection of axons with phenytoin in experimental allergic encephalomyelitis. Neuroreport. 2002 Oct 28;13(15):1909-12. doi: 10.1097/00001756-200210280-00015. PubMed 12395089 ↗
  • 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. doi: 10.1167/iovs.05-0618. PubMed 16249495 ↗
  • 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. doi: 10.1001/archopht.124.8.1111. PubMed 16908813 ↗
  • 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. doi: 10.1016/s0161-6420(02)01296-4. PubMed 12511365 ↗
  • 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):538-46. doi: 10.1016/s0002-9394(02)01683-5. PubMed 12383810 ↗
  • 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. doi: 10.1167/iovs.04-1174. PubMed 15980233 ↗
  • 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. doi: 10.1167/iovs.05-0294. PubMed 16123421 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00739154
Lead sponsor
Rabin Medical Center
First posted
Aug 21, 2008
Start date
Nov 2008
Primary completion
Nov 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Aug 21, 2008

Study contacts

Omer Y Bialer, MD
Contact
omerb2@vlalit.org.il
972-39376100
Dov Weinberger, MD
Contact
dwin@clalit.org.il
972-39376101
Omer Y Bialer, MD
study director · Rabin medical center, Petah Tikva, Israel
Dan Gaa'ton, MD
study director · Rabin medical center, Petah-Tikva, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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