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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenytoin | Experimental | patients received phenytoin 100mg three time daily up to 3 months |
|
| placebo | Experimental | patients received placebo 100 mg three time daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenytoin | Drug | 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Macular Layer Thickness | macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography | Measured at baseline and month 1, 6 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Center Farabi Hosoital | Tehran | 3542168325 | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenytoin | patients received phenytoin 100mg three time daily up to 3 months Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later. |
| FG001 | Placebo | patients received placebo 100 mg three time daily for 3 months placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenytoin | patients received phenytoin 100mg three time daily up to 3 months Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | incomplete follow up from baseline to 6 month | Posted | Mean | Standard Deviation | micron | Measured at baseline and month 1, 6 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenytoin | patients received phenytoin 100mg three time daily up to 3 months Phenytoin: 100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| steven johnson | Skin and subcutaneous tissue disorders | Systematic Assessment | steven johnson syn,Stevens-Johnson syndrome (SJS) is a type of severe skin reaction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment | sever skin reaction to drug except sjs |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr.alireza gholizade | assistant | 989112550646 | a.gholizade13@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2019 | Apr 14, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2019 | Apr 14, 2019 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2019 | Jul 5, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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participant , investigator
| placebo | Drug | 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later. |
|
patients received placebo 100 mg three time daily for 3 months
placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 6 subjects in phenytoin group and 3 subjects in placebo group were excluded from our study and this left 15 patients in phenytoin and 47 subjects in placebo group to be analysed. | Number | participants |
|
|
|
| Primary | Macular Layer Thickness | macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography | incomplete follow up | Posted | Mean | Standard Deviation | micron | 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. | incomplete follow up | Posted | Mean | Standard Deviation | log mar | 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). | incomplete follow up | Posted | Mean | Standard Deviation | db | 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 | incomplete follow up | Posted | Mean | Standard Deviation | micron | Measured at baseline and month1 ,6 |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 4 |
| 21 |
| EG001 | Placebo | patients received placebo 100 mg three time daily for 3 months placebo: 100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later. | 0 | 50 | 0 | 50 | 0 | 50 |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 1 month |
|
|
| 6 months |
|
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| 6 months |
|
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| 6 months MD |
|
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| 1 month |
|
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| 6 months |
|
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