Surgery for Traumatic Optic Neuropathy

Traumatic Optic Neuropathy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Nerve Injuries
• Traumatic Optic Neuropathy

• NCT number: NCT02711982
• Study type: Interventional
• Source: Shanghai Changzheng Hospital
• Contact: Lijun Hou, MD,PhD
• Phone: 86 21 81885671
• Email: houlijunsmmu@163.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2010
• Completion date: December 2020