Surgery for Traumatic Optic Neuropathy

Not Applicable

• Conditions: Traumatic Optic Neuropathy
• Interventions: Drug: methylprednisolone; Procedure: Optic canal and optic nerve sheath decompression

• Registration Number: NCT02711982
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone	methylprednisolone	a maximum daily dose of 1 g of methylprednisolone
Optic nerve decompression	Optic canal and optic nerve sheath decompression	Optic canal and optic nerve sheath decompression within 5 days from trauma occur.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurosurgery,ShangHai ChangZheng Hospital; 🇨🇳 ShangHai, Shanghai, China