Optic Neuritis Clinical Trial
Official title:
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
Verified date | April 2018 |
Source | Tehran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | January 2, 2019 |
Est. primary completion date | November 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist) - willing to receive a steroidal regimen - no pathologic finding in first oct - no pathology and history of optic neuritis in contralateral eye - <14 days since onset visual loss Exclusion Criteria: - Contraindication or known allergy to Phenytoin - Use of a calcium channel or sodium channel blocker in the past 2 months - Corticosteroid use in the past 2 months - Pregnancy - Significant cardiac, renal or liver abnormalities - Prior clinical episode of optic neuritis in either eye - Bilateral acute optic neuritis - Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function - Refractive error of greater than +5 or -5 diopters - Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Eye Research Center Farabi Hosoital | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retinal Ganglion Cell Inner Plexiform Layer Thickness | ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography | Measured at baseline and month 1, 6 | |
Primary | Macular Layer Thickness | macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography | Measured at baseline and month 1, 6 | |
Primary | Best Corrected Visual Acuity | Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation. | at baseline and month 6 | |
Primary | Visual Field Mean Deviation in Decibel | The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California). | Measured at baseline and month 6 | |
Secondary | Retinal Nerve Fibre Layer Thickness in Micrometer | Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography | Measured at baseline and month1 ,6 |
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