Protective Effect of Phenytoin on Glaucoma

August 20, 2008 updated by: Rabin Medical Center

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah-Tikva, Israel, 49100
        • Beilinson Hospital, Rabin medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients of a tertiary hospital's specialized epilepsy clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • visual acuity less then 6/60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peripapillary RNFL thickness
Time Frame: immediate
immediate

Secondary Outcome Measures

Outcome Measure
Time Frame
corrected pattern standard deviation in perimetric visual field
Time Frame: immediate
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (ESTIMATE)

August 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005062
  • non

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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