Surgery for Traumatic Optic Neuropathy

Traumatic Optic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02711982
• Other study ID #: 2016TON Study
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2016
• Last updated: March 16, 2016
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: March 2016
• Source: Shanghai Changzheng Hospital
• Contact: Lijun Hou, MD,PhD
• Phone: 86 21 81885671
• Email: houlijunsmmu[@]163.com
• Is FDA regulated: No
• Health authority: China: Medical Department of Ceneral Logistics DepartmentChina: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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

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

Intervention

Procedure:
• Optic canal and optic nerve sheath decompression
within 5 days from trauma

Drug:
• methylprednisolone
within 5 days from trauma

Locations

Country	Name	City	State
China	Department of Neurosurgery,ShangHai ChangZheng Hospital	ShangHai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude and Latency of Visual-Evoked Potential	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	from trauma day to 60 days after trauma	Yes
Secondary	Vision level of Visual Acuity	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	from trauma day to 60 days after trauma	Yes