NCT02711982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

10.9 years

First QC Date

March 6, 2016

Last Update Submit

March 16, 2016

Conditions

Traumatic Optic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Vision level of Visual Acuity

    from trauma day to 60 days after trauma

Study Arms (2)

Optic nerve decompression

ACTIVE COMPARATOR

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

Procedure: Optic canal and optic nerve sheath decompression

methylprednisolone

ACTIVE COMPARATOR

a maximum daily dose of 1 g of methylprednisolone

Drug: methylprednisolone

Interventions

Optic canal and optic nerve sheath decompressionPROCEDURE

within 5 days from trauma

Also known as: optic decompression
Optic nerve decompression
methylprednisoloneDRUG

within 5 days from trauma

Also known as: steroids
methylprednisolone

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Glasgow Coma Scale，Score\<8
  • Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
  • Other Contraindications for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery,ShangHai ChangZheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Optic Nerve Injuries

Interventions

MethylprednisoloneSteroids

Condition Hierarchy (Ancestors)

Cranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesCraniocerebral TraumaTrauma, Nervous SystemEye DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Lijun Hou, MD,PhD

    Shanghai Changzheng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijun Hou, MD,PhD

CONTACT

86 21 81885671houlijunsmmu@163.com

Hai Jin, MD,PhD

CONTACT

86 21 81885688kingsea300809@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 17, 2016

Study Start

January 1, 2010

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)