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Protective Effect of Phenytoin on Glaucoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00739154
First received: August 20, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

August 20, 2008
August 20, 2008
November 2008
November 2010   (final data collection date for primary outcome measure)
peripapillary RNFL thickness [ Time Frame: immediate ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
corrected pattern standard deviation in perimetric visual field [ Time Frame: immediate ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Protective Effect of Phenytoin on Glaucoma
Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma

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

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

patients of a tertiary hospital's specialized epilepsy clinic

  • Primary Open Angle Glaucoma
  • Secondary Open Angle Glaucoma
  • Narrow-Angle Glaucomas
  • Normal Tension Glaucoma
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
December 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • visual acuity less then 6/60
Both
18 Years and older
No
Contact: Omer Y Bialer, MD 972-39376100 omerb2@vlalit.org.il
Contact: Dov Weinberger, MD 972-39376101 dwin@clalit.org.il
Israel
 
NCT00739154
005062, non
No
prof. Dov Weinberger, head of ophthalmology department, Rabin medical center
Rabin Medical Center
Not Provided
Study Director: Omer Y Bialer, MD Rabin medical center, Petah Tikva, Israel
Study Director: Dan Gaa'ton, MD Rabin medical center, Petah-Tikva, Israel
Rabin Medical Center
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP