Surgery for Traumatic Optic Neuropathy

Sponsor

Shanghai Changzheng Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02711982

Collaborator

RenJi Hospital (Other)

Enrollment

Location

Arms

131

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Optic Neuropathy	Procedure: Optic canal and optic nerve sheath decompression Drug: methylprednisolone	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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