Traumatic Optic Neuropathy
Conditions
Keywords
Traumatic optic neuropathy, Erythropoietin, EPO, Eprex
Brief summary
After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.
Detailed description
Patients with TON will be visited. After being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of EPO to which patients and outcome assessors will be masked. They will be assessed at different follow up time periods with the last follow up of at least 3 months.
Interventions
DRUGRecombinant human erythropoietin
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Sponsors
Mashhad University of Medical Sciences
Tehran University of Medical Sciences
Iran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO
Intervention model description
3 treatment groups of patients with TON will receive different total dose of EPO.
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Having indirect traumatic optic neuropathy(with normal eye and fundus exam) 2. Trauma to treatment interval of 3 weeks and less 3. Age of 7 years and more
Exclusion criteria
1. Direct optic neuropathy, 2. Glaucoma, 3. Any retinopathy 4. Globe laceration 5. Age under 7 6. Hypertension, 7. Polycythemia, 8. Creatinin more than 3 mg/dl, 9. Sensitivity to EPO 10. Patients who have received any other form of treatment for their traumatic optic neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean LogMAR Best corrected visual acuity (BCVA) from 20/20 to no light perception (NLP) as assessed by Snellen visual acuity chart and analyzed based on mean LogMAR change. | Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months | Best corrected Visual acuity is measured (Snellen eye chart) and recorded as 20/20-20/25, 20/30, 20/40, 20, 50, 20/70, 20/100, 20/200 and then counting finger (CF), hand motion (HM), light perception (LP), and no light perception (NLP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Log Unit of Relative afferent pupillary defect (RAPD) from 0.3 to 1.8 log unit as assessed by Neutral density filter | Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months | RAPD will be measured based on six log unit of 0.3, 0.6, 0.9, 1.2, 1.5,and 1.8 in which the higher the number the higher the severity score of RAPD. |
| Change in Mean number of visible color plates in Color vision test book. It is from 14/14 to 0/14 as assessed by Ishihara 14-plate color test book | Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months | Using Ishihara 14-plate color vision test book, the color vision will be recorded as a fraction of 14 plates; e.g. 10/14. Patients with lower than 20/200 vision will have 0/14 since they can not read the color plates. |
| Number of patients with treatment related adverse effects as assessed by history taking (change in mood, vertigo, faint), examination (blood pressure) and blood tests (CBC, BUN, Cr., K, Na, PT, PTT, INR, Ca., Ph) | before treatment and on day 1, 2 and 3 after treatment. | history taking (change in mood, vertigo, faint), examination (blood pressure) and blood tests (CBC, BUN, Cr., K, Na, PT, PTT, INR, Ca., Ph) will be performed before treatment and on day 1, 2 and 3 after treatment. |
Countries
Iran
Outcome results
None listed