Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
|ClinicalTrials.gov Identifier: NCT02939937|
Recruitment Status : Completed
First Posted : October 20, 2016
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Optic Neuritis||Drug: Phenytoin Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||participant , investigator|
|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|
|Actual Study Start Date :||March 9, 2017|
|Actual Primary Completion Date :||November 11, 2018|
|Actual Study Completion Date :||January 2, 2019|
patients received phenytoin 100mg three time daily up to 3 months
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
Other Name: epanutin
patients received placebo 100 mg three time daily for 3 months
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
- Retinal Ganglion Cell Inner Plexiform Layer Thickness [ Time Frame: Measured at baseline and month 1, 6 ]ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
- Macular Layer Thickness [ Time Frame: Measured at baseline and month 1, 6 ]macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
- Best Corrected Visual Acuity [ Time Frame: at baseline and month 6 ]Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
- Visual Field Mean Deviation in Decibel [ Time Frame: Measured at baseline and month 6 ]The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
- Retinal Nerve Fibre Layer Thickness in Micrometer [ Time Frame: Measured at baseline and month1 ,6 ]Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939937
|Iran, Islamic Republic of|
|Eye Research Center Farabi Hosoital|
|Tehran, Iran, Islamic Republic of, 3542168325|