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Protective Effect of Phenytoin on Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739154
Recruitment Status : Unknown
Verified August 2008 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2008
Last Update Posted : August 21, 2008
Information provided by:
Rabin Medical Center

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

Condition or disease
Primary Open Angle Glaucoma Secondary Open Angle Glaucoma Narrow-Angle Glaucomas Normal Tension Glaucoma

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Cohort Study of Association Between Steady State Phenytoin Treatment and Better Clinical Parameters of Glaucoma
Study Start Date : November 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Phenytoin

glaucoma patients who also suffer from epileptic disorder and receiving chronic oral Phenytoin treatment
glaucoma patients who also suffer from epileptic disorder receiving anti-convulsant treatment other then Phenytoin
glaucoma patients with no epileptic disorder and not receiving anti-convulsant treatment

Primary Outcome Measures :
  1. peripapillary RNFL thickness [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. corrected pattern standard deviation in perimetric visual field [ Time Frame: immediate ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • pregnancy
  • visual acuity less then 6/60

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739154

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Contact: Omer Y Bialer, MD 972-39376100
Contact: Dov Weinberger, MD 972-39376101

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Beilinson hospital, Rabin medical center
Petah-Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
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Study Director: Omer Y Bialer, MD Rabin medical center, Petah Tikva, Israel
Study Director: Dan Gaa'ton, MD Rabin medical center, Petah-Tikva, Israel
Publications of Results:

Other Publications:
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Responsible Party: prof. Dov Weinberger, head of ophthalmology department, Rabin medical center Identifier: NCT00739154    
Other Study ID Numbers: 005062
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Keywords provided by Rabin Medical Center:
retinal nerve fiber layer
corrected pattern standard deviation
visual acuity
optic disc cupping
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Low Tension Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases