Trial · NCT02939937
Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
NCT02939937, Phase 2, Completed, Tehran University of Medical Sciences; results first posted 2019-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis. Trials, record NCT02939937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02939937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
- NCT number
- NCT02939937
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Tehran University of Medical Sciences
- Conditions
- Optic Neuritis
- Interventions
- Phenytoin, placebo
- First posted
- 2016-10-20
- Last updated
- 2019-08-12
- Results first posted
- 2019-08-12
- Limitations and caveats
- 1. Shorter follow up~2. Poor compliance for oral drug intake
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retinal Ganglion Cell Inner Plexiform Layer Thickness | Measured at baseline and month 1, 6 | ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography |
| Primary | Macular Layer Thickness | Measured at baseline and month 1, 6 | macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography |
| Primary | Best Corrected Visual Acuity | at baseline and month 6 | Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation. |
| Primary | Visual Field Mean Deviation in Decibel | 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). |
| Secondary | Retinal Nerve Fibre Layer Thickness in Micrometer | Measured at baseline and month1 ,6 | Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Retinal Ganglion Cell Inner Plexiform Layer Thickness | Measured at baseline and month 1, 6 | incomplete follow up from baseline to 6 month | micron | MEAN |
| PRIMARY | Macular Layer Thickness | Measured at baseline and month 1, 6 | incomplete follow up | micron | MEAN |
| PRIMARY | Best Corrected Visual Acuity | at baseline and month 6 | incomplete follow up | log mar | MEAN |
| PRIMARY | Visual Field Mean Deviation in Decibel | Measured at baseline and month 6 | incomplete follow up | db | MEAN |
| SECONDARY | Retinal Nerve Fibre Layer Thickness in Micrometer | Measured at baseline and month1 ,6 | incomplete follow up | micron | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Phenytoin | baseline | 36.56 | Standard Deviation 6.61 | micron |
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Placebo | baseline | 34.65 | Standard Deviation 8.49 | micron |
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Phenytoin | 1 month | 31 | Standard Deviation 6.61 | micron |
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Placebo | 1 month | 29.42 | Standard Deviation 5.98 | micron |
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Phenytoin | 6 months | 30.70 | Standard Deviation 5.56 | micron |
| Retinal Ganglion Cell Inner Plexiform Layer Thickness | Placebo | 6 months | 32.12 | Standard Deviation 9.10 | micron |
| Macular Layer Thickness | Phenytoin | baseline | 262.73 | Standard Deviation 22.02 | micron |
| Macular Layer Thickness | Placebo | baseline | 265.98 | Standard Deviation 22.5 | micron |
| Macular Layer Thickness | Phenytoin | 1 month | 255 | Standard Deviation 19.72 | micron |
| Macular Layer Thickness | Placebo | 1 month | 264.39 | Standard Deviation 22.53 | micron |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phenytoin | 21 | |
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | COMPLETED | Phenytoin | 15 | |
| Overall Study | COMPLETED | Placebo | 47 | |
| Overall Study | NOT COMPLETED | Phenytoin | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | skin reaction | Skin and subcutaneous tissue disorders | Phenytoin | 4 | 21 | 4 |
| other | skin reaction | Skin and subcutaneous tissue disorders | Placebo | 0 | 50 | 0 |
| serious | steven johnson | Skin and subcutaneous tissue disorders | Phenytoin | 1 | 21 | 1 |
| serious | steven johnson | Skin and subcutaneous tissue disorders | Placebo | 0 | 50 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenytoin | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 50 |
| Total, other adverse events | Phenytoin | 4 | 21 |
| Total, other adverse events | Placebo | 0 | 50 |
| Total, serious adverse events | Phenytoin | 1 | 21 |
| Total, serious adverse events | Placebo | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phenytoin vs Placebo: deaths from any cause | Trial comparisons |
| Phenytoin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02939937
GET https://conductscience.org/api/trials/v1/NCT02939937/results?page=2