NCT01783847.

Trial name or title	Traumatic Optic Neuropathy Treatment Trial (TONTT)
Methods	Multicentre randomised placebo controlled Tehran University of Medical Sciences, Iran Mashhad University of Medical Sciences, Iran Shaheed Beheshti Medical University, Iran
Participants	Estimated enrolment: 100 participants Inclusion criteria: 1. indirect traumatic optic neuropathy (TON); 2. not more than 3 weeks between trauma and treatment allocation; and 3. normal fundoscopy Exclusion criteria: 1. other injuries affecting visual function; 2. direct TON; 3. glaucoma; diabetic retinopathy; uncontrolled hypertension; polycythaemia; 4. creatinine more than 3 mg/dl; 5. sensitivity to recombinant human erythropoietin (EPO); 6. hyperkalaemia; 7. women using the contraceptive pill; pregnant and breast feeding women; 8. history of stroke and cardiovascular diseases; and 9. malignancy
Interventions	The aim of this study is to compare the visual benefit of EPO with steroids or observation alone in indirect TON. Participants will be randomised to one of three treatment groups: Experimental group: 20,000 units of EPO per day, with intravenous infusions on 3 consecutive days. Active comparator group: 1 gram of methylprednisolone per day, with intravenous infusions on 3 consecutive days. If visual improvement occurs, the initial treatment phase with intravenous methylprednisolone will be followed by a course of oral steroids (1 mg/kg/day) for 11 days. Observation group: no treatment will be given.
Outcomes	Primary outcome: Change in visual acuity from baseline to 3 months after treatment. Secondary outcomes: Change in visual acuity, relative afferent pupillary defect, and colour vision from baseline to 1 day, 2 days, 3 days, 1 week, 2 weeks, 1 month, and 3 months after treatment. Change in visual fields from baseline to 3 months after treatment. This test will only be carried out if the participant's visual acuity is sufficiently good to allow visual fields to be performed reliably.
Starting date	February 2011
Contact information	Mohsen B Kashkouli, MD bahmanik@yahoo.com http://clinicaltrials.gov/show/NCT01783847
Notes	The trial will not be double masked given the different nature of the three treatment groups.