Oculomotor Nerve PalsyNCT03461809
A Retrospective Study of the Effects of Ocular Acupuncture on Ocular Motor Nerve Palsy
An observational study of Oculomotor Nerve Palsy and Trochlear Nerve Palsy, run by First Affiliated Hospital of Harbin Medical University.
Trial summary
This retrospective observational study is designed to assess the response to treatment with ocular acupuncture and its relative factors, in terms of diplopia status, ocular motility differences, and clinical features, in ocular motor nerve palsy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oculomotor Nerve Palsy, Trochlear Nerve Palsy, Abducens Nerve Paralysis
- What is being tested?
- Ocular acupuncture
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2018to 15 May 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with ocular motor nerve palsy who received ocular acupuncture.
Who may be able to join
- Age over 18 years old
- Patient who received at lease 1 times of ocular acupuncture treatment
- Patient who received full set of ophthalmology \& neurology assessment pre- and post-treatment.
Who cannot join
- patient who combined with extraocular muscles diseases, eg.thyroid eye disease
- patient who underwent periocular surgery
- patient who combined with congenital ocular motor nerve palsy, eg. Brown syndrome.
- patient who had untreated condition which may lead to ocular motor nerve palsy such as intracranial aneurysm and brain tumor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients
This retrospective observational study is designed to assess the response to treatment with ocular acupuncture and its relative factors, in terms of diplopia status, ocular motility differences, and clinical features, in ocular motor nerve palsy patients. During this study, a retrospective data collection will be carried out using the information contained in the medical record of aimed patients, provided that the treatment with ocular acupuncture.
- Being tested
- Ocular acupuncture
- Keywords
- diplopia; ocular motor nerve palsy; acupuncture
- Medical subject headings
- Oculomotor Nerve Diseases, Trochlear Nerve Diseases, Abducens Nerve Diseases, Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular acupunctureOther
Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ocular motor nerve palsy treated by ocular acupuncture | Ocular motor nerve palsy patients who received ocular acupuncture treatment Receives: Other: Ocular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy rate (Cure, Effective and Invalid)
Clinical efficacy rate (Cure, Effective and Invalid) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Cure and effective proportional to number of all cases.
Measured: Through study completion, an average of 1 month.
Secondary outcomes (3)
Diplopia angle
Patient's diplopia angle obtained by retrospective chart review.
Measured: Through study completion, an average of 2 weeks.
Eyeball movement distance
Patient's eyeball movement distance obtained by retrospective chart review.
Measured: Through study completion, an average of 2 weeks.
Distance between upper and lower eyelid.
Patient's distance between upper and lower eyelid obtained by retrospective chart review.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start15 Mar 2018 (estimated)
- Primary completion15 May 2018 (estimated)
- Study completion15 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oculomotor Nerve PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461809
- Sponsor's protocol ID
- 20180204
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients
- ClinicalTrials.gov ID
- NCT03461809
- Acronym / sponsor ID
- 20180204
- Keywords
- diplopia; ocular motor nerve palsy; acupuncture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (estimated)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 May 2018 (estimated)
- First posted
- 12 Mar 2018 (actual)
- 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.
This retrospective observational study is designed to assess the response to treatment with ocular acupuncture and its relative factors, in terms of diplopia status, ocular motility differences, and clinical features, in ocular motor nerve palsy patients. During this study, a retrospective data collection will be carried out using the information contained in the medical record of aimed patients, provided that the treatment with ocular acupuncture.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular motor nerve palsy treated by ocular acupuncture | – | Other: Ocular acupunctureOcular motor nerve palsy patients who received ocular acupuncture treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ocular motor nerve palsy who received ocular acupuncture.
Key inclusion criteria (3 listed)
- Age over 18 years old
- Patient who received at lease 1 times of ocular acupuncture treatment
- Patient who received full set of ophthalmology \& neurology assessment pre- and post-treatment.
Key exclusion criteria (4 listed)
- patient who combined with extraocular muscles diseases, eg.thyroid eye disease
- patient who underwent periocular surgery
- patient who combined with congenital ocular motor nerve palsy, eg. Brown syndrome.
- patient who had untreated condition which may lead to ocular motor nerve palsy such as intracranial aneurysm and brain tumor.
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 |
|---|---|---|
| Ocular acupuncturePatient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes. | Other | Ocular motor nerve palsy treated by ocular acupuncture |
Primary outcome
Clinical efficacy rate (Cure, Effective and Invalid)
Time frame: Through study completion, an average of 1 month.
Clinical efficacy rate (Cure, Effective and Invalid) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Cure and effective proportional to number of all cases.
3 secondary outcomes
Diplopia angle
Time frame: Through study completion, an average of 2 weeks.
Eyeball movement distance
Time frame: Through study completion, an average of 2 weeks.
Distance between upper and lower eyelid.
Time frame: Through study completion, an average of 2 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oculomotor Nerve Palsy and Trochlear Nerve Palsy, run by First Affiliated Hospital of Harbin Medical University.
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 4 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 lingyun zhou, PHD (85556000 ext. 3749, no1zhly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy rate (Cure, Effective and Invalid) (time frame: Through study completion, an average of 1 month.). 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 12 Mar 2018.