Clinical Trial: Surgery for Traumatic Optic Neuropathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
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.
Detailed Summary: surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
Sponsor: Shanghai Changzheng Hospital
Current Primary Outcome: Amplitude and Latency of Visual-Evoked Potential [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome: Vision level of Visual Acuity [ Time Frame: 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
Original Secondary Outcome: Same as current
Information By: Shanghai Changzheng Hospital
Dates:
Date Received: March 6, 2016
Date Started: January 2010
Date Completion: December 2020
Last Updated: March 16, 2016
Last Verified: March 2016
