Traumatic Optic Neuropathy
Conditions
Brief summary
The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary mechanism of injury. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. In this study, investigators aim to make a randomized controlled trial to certify the efficiency of optic nerve canal decompression for TON patients.
Detailed description
surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
Interventions
PROCEDUREOptic canal and optic nerve sheath decompression
within 5 days from trauma
DRUGmethylprednisolone
within 5 days from trauma
Sponsors
RenJi Hospital
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with the history of Traumatic Brain Injury or Craniofacial Trauma * Optic nerve compression（intraneural edema, nerve sheath hematoma or canal fracture with impingement) * Amplitude and latency abnormal or Ratio of amplitude of abnormal to normal side.
Exclusion criteria
* Glasgow Coma Scale，Score\<8 * Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50% * Other Contraindications for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude and Latency of Visual-Evoked Potential | from trauma day to 60 days after trauma | Name of Scale: Visual-Evoked Potential Physiological Parameter: Amplitude and Latency Questionnaire: Trauma day and 1 day, 2 days, 3 days, 7 days, 14 days, 30 days and 60 days after trauma. Two more test for the day before surgery（Medical） and the day after surgery(Medical). Measurement collection: Inpatient and outpatient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vision level of Visual Acuity | from trauma day to 60 days after trauma | Name of Scale: Level Vision and Visual acuity chart from 0.1 to 1.5 Physiological Parameter: light perception, hand motion and Visual Acuity Chart from 0.1 to 1.5 Questionnaire: Trauma day and 1 day, 2 days, 3 days, 7 days, 14 days, 30 days and 60 days after trauma. Two more test for the day before surgery（Medical） and the day after surgery(Medical). Measurement collection: Inpatient and outpatient |
Countries
China
Contacts
Primary ContactLijun Hou, MD,PhD
Backup ContactHai Jin, MD,PhD
Outcome results
None listed