Surgery for Traumatic Optic Neuropathy

Study Overview
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Brief Summary
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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
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surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.

Official Title
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Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study

Conditions
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Traumatic Optic Neuropathy

Intervention / Treatment
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* Procedure: Optic canal and optic nerve sheath decompression
* Drug: methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optic nerve decompression<br>Optic canal and optic nerve sheath decompression within 5 days from trauma occur. | Procedure: Optic canal and optic nerve sheath decompression<br>* within 5 days from trauma<br>* Other names: optic decompression;|
| Active Comparator: methylprednisolone<br>a maximum daily dose of 1 g of methylprednisolone | Drug: methylprednisolone<br>* within 5 days from trauma<br>* Other names: steroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude and Latency of Visual-Evoked Potential | 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 | from trauma day to 60 days after trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision level of Visual Acuity | 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 | from trauma day to 60 days after trauma |