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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
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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.
surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optic nerve decompression | Active Comparator | Optic canal and optic nerve sheath decompression within 5 days from trauma occur. |
|
| methylprednisolone | Active Comparator | a maximum daily dose of 1 g of methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optic canal and optic nerve sheath decompression | Procedure | within 5 days from trauma |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijun Hou, MD,PhD | Contact | 86 21 81885671 | houlijunsmmu@163.com | |
| Hai Jin, MD,PhD | Contact | 86 21 81885688 | kingsea300809@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lijun Hou, MD,PhD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery,ShangHai ChangZheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
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| ID | Term |
|---|---|
| D020221 | Optic Nerve Injuries |
| ID | Term |
|---|---|
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| methylprednisolone | Drug | within 5 days from trauma |
|
|
| from trauma day to 60 days after trauma |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |