Surgery for Traumatic Optic Neuropathy

March 16, 2016 updated by: Hou Lijun, Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China, 200003
        • Recruiting
        • Department of Neurosurgery,ShangHai ChangZheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optic nerve decompression
Optic canal and optic nerve sheath decompression within 5 days from trauma occur.
Procedure: Optic canal and optic nerve sheath decompression
within 5 days from trauma
Other Names:
  • optic decompression
Active Comparator: methylprednisolone
a maximum daily dose of 1 g of methylprednisolone
Drug: methylprednisolone
within 5 days from trauma
Other Names:
  • steroids

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016TON Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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