Surgery for Traumatic Optic Neuropathy

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Traumatic Optic Neuropathy

Treatments: Drug: methylprednisolone; Procedure: Optic canal and optic nerve sheath decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT02711982

2016TON Study

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2 estimated patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Optic nerve decompression

Active Comparator group

Description:

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

Treatment:

Procedure: Optic canal and optic nerve sheath decompression

methylprednisolone

Active Comparator group

Description:

a maximum daily dose of 1 g of methylprednisolone

Treatment:

Drug: methylprednisolone