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Surgery for Traumatic Optic Neuropathy

Primary Purpose

Traumatic Optic Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Optic canal and optic nerve sheath decompression
methylprednisolone
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Optic Neuropathy

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurosurgery,ShangHai ChangZheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Optic nerve decompression

methylprednisolone

Arm Description

Optic canal and optic nerve sheath decompression within 5 days from trauma occur.

a maximum daily dose of 1 g of methylprednisolone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2016
Last Updated
March 16, 2016
Sponsor
Shanghai Changzheng Hospital
Collaborators
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02711982
Brief Title
Surgery for Traumatic Optic Neuropathy
Official Title
Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Optic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optic nerve decompression
Arm Type
Active Comparator
Arm Description
Optic canal and optic nerve sheath decompression within 5 days from trauma occur.
Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
a maximum daily dose of 1 g of methylprednisolone
Intervention Type
Procedure
Intervention Name(s)
Optic canal and optic nerve sheath decompression
Other Intervention Name(s)
optic decompression
Intervention Description
within 5 days from trauma
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
steroids
Intervention Description
within 5 days from trauma
Primary Outcome Measure Information:
Title
Amplitude and Latency of Visual-Evoked Potential
Description
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
Time Frame
from trauma day to 60 days after trauma
Secondary Outcome Measure Information:
Title
Vision level of Visual Acuity
Description
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
Time Frame
from trauma day to 60 days after trauma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Hou, MD,PhD
Phone
86 21 81885671
Email
houlijunsmmu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hai Jin, MD,PhD
Phone
86 21 81885688
Email
kingsea300809@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijun Hou, MD,PhD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery,ShangHai ChangZheng Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Jin, M.D.,PhD
Phone
86 21 81885671
Email
kingsea300809@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgery for Traumatic Optic Neuropathy

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