Surgery for Traumatic Optic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Traumatic Optic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Optic nerve decompression

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

Group Type ACTIVE_COMPARATOR

Optic canal and optic nerve sheath decompression

Intervention Type PROCEDURE

within 5 days from trauma

methylprednisolone

a maximum daily dose of 1 g of methylprednisolone

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

within 5 days from trauma

Interventions

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Optic canal and optic nerve sheath decompression

within 5 days from trauma

Intervention Type PROCEDURE

methylprednisolone

within 5 days from trauma

Intervention Type DRUG

Other Intervention Names

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optic decompression steroids

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No