Traumatic Optic NeuropathyNCT02711982
Surgery for Traumatic Optic Neuropathy
A study testing Optic canal and optic nerve sheath decompression and methylprednisolone in people with Traumatic Optic Neuropathy, run by Shanghai Changzheng Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Traumatic Optic Neuropathy
- What is being tested?
- Optic canal and optic nerve sheath decompression and methylprednisolone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Glasgow Coma Scale，Score<8
- Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
- Other Contraindications for surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery,ShangHai ChangZheng Hospital
Shanghai, Shanghai Municipality, 200003
Hai Jin, M.D.,PhD, 86 21 81885671, kingsea300809@163.com
About this study
Official title: Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
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.
Read the detailed description
surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
- Conditions
- Traumatic Optic Neuropathy
- Being tested
- Optic canal and optic nerve sheath decompression, methylprednisolone
- Medical subject headings
- Optic Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic canal and optic nerve sheath decompressionProcedure or surgery
Also called optic decompression
within 5 days from trauma
Also called steroids
within 5 days from trauma
| Study group | Role | What they receive |
|---|---|---|
| Optic nerve decompression | Active comparator | Optic canal and optic nerve sheath decompression within 5 days from trauma occur. Receives: Procedure: Optic canal and optic nerve sheath decompression |
| methylprednisolone | Active comparator | a maximum daily dose of 1 g of methylprednisolone Receives: Drug: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from trauma day to 60 days after trauma
Secondary outcomes (1)
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
Measured: from trauma day to 60 days after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Hou Lijun, Shanghai Changzheng Hospital
- Investigators
- Lijun Hou, MD,PhD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711982
- Sponsor's protocol ID
- 2016TON Study
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02711982
- Acronym / sponsor ID
- 2016TON Study
- Conditions
- Traumatic Optic Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Jan 2010
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optic nerve decompression | Active comparator | Procedure: Optic canal and optic nerve sheath decompressionOptic canal and optic nerve sheath decompression within 5 days from trauma occur. |
| methylprednisolone | Active comparator | Drug: methylprednisolonea maximum daily dose of 1 g of methylprednisolone |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Glasgow Coma Scale，Score<8
- Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
- Other Contraindications for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic canal and optic nerve sheath decompressionAlso: optic decompressionwithin 5 days from trauma | Procedure or surgery | Optic nerve decompression |
| methylprednisoloneAlso: steroidswithin 5 days from trauma | Drug | methylprednisolone |
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
1 secondary outcome
Vision level of Visual Acuity
Time frame: from trauma day to 60 days after trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun Hou, MD,PhD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic canal and optic nerve sheath decompression and methylprednisolone in people with Traumatic Optic Neuropathy, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijun Hou, MD,PhD (86 21 81885671, houlijunsmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude and Latency of Visual-Evoked Potential (time frame: from trauma day to 60 days after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.