Status:
COMPLETED
Traumatic Optic Neuropathy Treatment Trial 2
Lead Sponsor:
Iran University of Medical Sciences
Collaborating Sponsors:
Mashhad University of Medical Sciences
Tehran University of Medical Sciences
Conditions:
Traumatic Optic Neuropathy
Eligibility:
All Genders
7+ years
Phase:
PHASE3
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 ...
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 administr...
Eligibility Criteria
Inclusion
- Having indirect traumatic optic neuropathy(with normal eye and fundus exam)
- Trauma to treatment interval of 3 weeks and less
- Age of 7 years and more
Exclusion
- Direct optic neuropathy,
- Glaucoma,
- Any retinopathy
- Globe laceration
- Age under 7
- Hypertension,
- Polycythemia,
- Creatinin more than 3 mg/dl,
- Sensitivity to EPO
- Patients who have received any other form of treatment for their traumatic optic neuropathy
Key Trial Info
Start Date :
January 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03308448
Start Date
January 6 2018
End Date
March 2 2023
Last Update
March 8 2024
Active Locations (3)
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1
Iran University of Medical Sciences
Tehrān, Tehran Province, Iran
2
Mashhad University of Medical Sciences
Mashhad, Iran
3
Tehran University of Medical Sciences
Tehran, Iran