Trial record 2 of 949 for:    "Glaucoma"

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
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • peripapillary RNFL thickness [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • corrected pattern standard deviation in perimetric visual field [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of a tertiary hospital's specialized epilepsy clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • visual acuity less then 6/60
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739154

Contacts
Contact: Omer Y Bialer, MD 972-39376100 omerb2@vlalit.org.il
Contact: Dov Weinberger, MD 972-39376101 dwin@clalit.org.il

Locations
Israel
Beilinson hospital, Rabin medical center
Petah-Tikva, Israel, 49100
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: prof. Dov Weinberger, head of ophthalmology department, Rabin medical center
ClinicalTrials.gov Identifier: NCT00739154     History of Changes
Other Study ID Numbers: 005062, non
Study First Received: August 20, 2008
Last Updated: August 20, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
glaucoma
Phenytoin
retinal nerve fiber layer
corrected pattern standard deviation
visual acuity
optic disc cupping

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Phenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014