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a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis
Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days. As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision. There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage. The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
Eye Research Center Farabi Hosoital
Tehran, Iran
Start Date
March 9, 2017
Primary Completion Date
November 11, 2018
Completion Date
January 2, 2019
Last Updated
August 12, 2019
71
ACTUAL participants
Phenytoin
DRUG
placebo
DRUG
Lead Sponsor
Tehran University of Medical Sciences
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03401879