Trial · NCT01783847
Traumatic Optic Neuropathy Treatment Trial (TONTT)
NCT01783847, Phase 1, Phase 2, Completed, Tehran University of Medical Sciences; results first posted 2018-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Traumatic Optic Neuropathy Treatment Trial (TONTT). Trials, record NCT01783847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01783847
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Traumatic Optic Neuropathy Treatment Trial (TONTT)
- NCT number
- NCT01783847
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 117 participants, actual
- Lead sponsor
- Tehran University of Medical Sciences
- Conditions
- Traumatic Optic Neuropathy
- Interventions
- Recombinant human erythropoietin (EPO), Observation, Methyl prednisolone
- First posted
- 2013-02-05
- Last updated
- 2019-05-07
- Results first posted
- 2018-09-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Change/Improvement Visual Acuity From the Beseline | Change from baseline at least 3 months after treatment | Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR\[12\], 2) 0.3 change in logMAR (improvement, deterioration, and no change) \[12,16\] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. |
| Secondary | Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4 | Change from baseline at least 3 months after treatment | A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Change/Improvement Visual Acuity From the Beseline | Change from baseline at least 3 months after treatment | Seventeen patients with incomplete follow up and not following the treatment protocol were also excluded during the study. There were 100 patients (100 eyes) who completed the study protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4 | Change from baseline at least 3 months after treatment | Seventeen patients dropped out of the study due to incomplete follow-up (16 patients from EPO and one patient from Methylprednisolone group) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Change/Improvement Visual Acuity From the Beseline | Recombinant Human Erythropoietin (EPO) | 28 | Participants | ||
| Number of Participants With Change/Improvement Visual Acuity From the Beseline | Methylprednisolone | 3 | Participants | ||
| Number of Participants With Change/Improvement Visual Acuity From the Beseline | Observation | 5 | Participants | ||
| Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4 | Recombinant Human Erythropoietin (EPO) | 26 | Participants | ||
| Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4 | Methylprednisolone | 7 | Participants | ||
| Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4 | Observation | 8 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Human Erythropoietin (EPO) | 85 | |
| Overall Study | STARTED | Methylprednisolone | 16 | |
| Overall Study | STARTED | Observation | 16 | |
| Overall Study | COMPLETED | Recombinant Human Erythropoietin (EPO) | 69 | |
| Overall Study | COMPLETED | Methylprednisolone | 15 | |
| Overall Study | COMPLETED | Observation | 16 | |
| Overall Study | NOT COMPLETED | Recombinant Human Erythropoietin (EPO) | 16 | |
| Overall Study | NOT COMPLETED | Methylprednisolone | 1 | |
| Overall Study | NOT COMPLETED | Observation | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Human Erythropoietin (EPO) | 0 | 69 |
| Total, all-cause mortality | Methylprednisolone | 0 | 15 |
| Total, all-cause mortality | Observation | 0 | 16 |
| Total, other adverse events | Recombinant Human Erythropoietin (EPO) | 0 | 69 |
| Total, other adverse events | Methylprednisolone | 0 | 15 |
| Total, other adverse events | Observation | 0 | 16 |
| Total, serious adverse events | Recombinant Human Erythropoietin (EPO) | 0 | 69 |
| Total, serious adverse events | Methylprednisolone | 0 | 15 |
| Total, serious adverse events | Observation | 0 | 16 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01783847
GET https://conductscience.org/api/trials/v1/NCT01783847/registered