Protective Effect of Phenytoin on Glaucoma

NCT00739154 | Unknown

• 2 other identifiers: 005062non
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• peripapillary RNFL thickness

  immediate

Secondary Outcomes (1)

• corrected pattern standard deviation in perimetric visual field

  immediate

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of a tertiary hospital's specialized epilepsy clinic

You may qualify if:

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

You may not qualify if:

• pregnancy
• visual acuity less then 6/60

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Beilinson hospital, Rabin medical center

Petah Tikva, 49100, Israel

Location

Related Publications (16)

• Chidlow G, Wood JP, Casson RJ. Pharmacological neuroprotection for glaucoma. Drugs. 2007;67(5):725-59. doi: 10.2165/00003495-200767050-00006.

  PMID: 17385943 BACKGROUND

• 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.

  PMID: 16765680 BACKGROUND

• 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.

  PMID: 16239127 BACKGROUND

• 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.

  PMID: 1957169 BACKGROUND

• 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.

  PMID: 16386972 BACKGROUND

• 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.

  PMID: 1454314 RESULT

• 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.

  PMID: 17532502 RESULT

• 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.

  PMID: 5053695 RESULT

• 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.

  PMID: 12126947 RESULT

• 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.

  PMID: 12395089 RESULT

• 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.

  PMID: 16249495 RESULT

• 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.

  PMID: 16908813 RESULT

• 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.

  PMID: 12511365 RESULT

• 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.

  PMID: 12383810 RESULT

• 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.

  PMID: 15980233 RESULT

• 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.

  PMID: 16123421 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Low Tension Glaucoma; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Omer Y Bialer, MD

  Rabin medical center, Petah Tikva, Israel

  STUDY DIRECTOR

• Dan Gaa'ton, MD

  Rabin medical center, Petah-Tikva, Israel

  STUDY DIRECTOR

Central Study Contacts

Omer Y Bialer, MD

CONTACT

972-39376100; omerb2@vlalit.org.il

Dov Weinberger, MD

CONTACT

972-39376101; dwin@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

IL (1)