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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryRetinal Ganglion Cell Inner Plexiform Layer ThicknessMeasured at baseline and month 1, 6ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography
PrimaryMacular Layer ThicknessMeasured at baseline and month 1, 6macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography
PrimaryBest Corrected Visual Acuityat baseline and month 6Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.
PrimaryVisual Field Mean Deviation in DecibelMeasured at baseline and month 6The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).
SecondaryRetinal Nerve Fibre Layer Thickness in MicrometerMeasured at baseline and month1 ,6Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYRetinal Ganglion Cell Inner Plexiform Layer ThicknessMeasured at baseline and month 1, 6incomplete follow up from baseline to 6 monthmicronMEAN
PRIMARYMacular Layer ThicknessMeasured at baseline and month 1, 6incomplete follow upmicronMEAN
PRIMARYBest Corrected Visual Acuityat baseline and month 6incomplete follow uplog marMEAN
PRIMARYVisual Field Mean Deviation in DecibelMeasured at baseline and month 6incomplete follow updbMEAN
SECONDARYRetinal Nerve Fibre Layer Thickness in MicrometerMeasured at baseline and month1 ,6incomplete follow upmicronMEAN

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPhenytoinbaseline36.56Standard Deviation 6.61micron
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPlacebobaseline34.65Standard Deviation 8.49micron
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPhenytoin1 month31Standard Deviation 6.61micron
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPlacebo1 month29.42Standard Deviation 5.98micron
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPhenytoin6 months30.70Standard Deviation 5.56micron
Retinal Ganglion Cell Inner Plexiform Layer ThicknessPlacebo6 months32.12Standard Deviation 9.10micron
Macular Layer ThicknessPhenytoinbaseline262.73Standard Deviation 22.02micron
Macular Layer ThicknessPlacebobaseline265.98Standard Deviation 22.5micron
Macular Layer ThicknessPhenytoin1 month255Standard Deviation 19.72micron
Macular Layer ThicknessPlacebo1 month264.39Standard Deviation 22.53micron

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPhenytoin21
Overall StudySTARTEDPlacebo50
Overall StudyCOMPLETEDPhenytoin15
Overall StudyCOMPLETEDPlacebo47
Overall StudyNOT COMPLETEDPhenytoin6
Overall StudyNOT COMPLETEDPlacebo3

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherskin reactionSkin and subcutaneous tissue disordersPhenytoin4214
otherskin reactionSkin and subcutaneous tissue disordersPlacebo0500
serioussteven johnsonSkin and subcutaneous tissue disordersPhenytoin1211
serioussteven johnsonSkin and subcutaneous tissue disordersPlacebo0500

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPhenytoin021
Total, all-cause mortalityPlacebo050
Total, other adverse eventsPhenytoin421
Total, other adverse eventsPlacebo050
Total, serious adverse eventsPhenytoin121
Total, serious adverse eventsPlacebo050

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.

ComparisonSource
Phenytoin vs Placebo: deaths from any causeTrial comparisons
Phenytoin vs Placebo: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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