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A Retrospective Study of the Effects of Ocular Acupuncture on Ocular Motor Nerve Palsy

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ClinicalTrials.gov Identifier: NCT03461809
Recruitment Status : Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief 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. 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.

Condition or disease Intervention/treatment
Oculomotor Nerve Palsy Trochlear Nerve Palsy Abducens Nerve Paralysis Other: Ocular acupuncture

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018


Group/Cohort Intervention/treatment
Ocular motor nerve palsy treated by ocular acupuncture
Ocular motor nerve palsy patients who received ocular acupuncture treatment
Other: Ocular acupuncture
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Diplopia angle [ Time Frame: Through study completion, an average of 2 weeks. ]
    Patient's diplopia angle obtained by retrospective chart review.

  2. Eyeball movement distance [ Time Frame: Through study completion, an average of 2 weeks. ]
    Patient's eyeball movement distance obtained by retrospective chart review.

  3. Distance between upper and lower eyelid. [ Time Frame: Through study completion, an average of 2 weeks. ]
    Patient's distance between upper and lower eyelid obtained by retrospective chart review.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with ocular motor nerve palsy who received ocular acupuncture.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461809


Contacts
Contact: lingyun zhou, PHD 85556000 ext 3749 no1zhly@163.com
Contact: tiejuan liu, PHD 85556000 ext 5226 ltj850722@126.com

Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University

Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03461809     History of Changes
Other Study ID Numbers: 20180204
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:
diplopia; ocular motor nerve palsy; acupuncture

Additional relevant MeSH terms:
Paralysis
Oculomotor Nerve Diseases
Trochlear Nerve Diseases
Abducens Nerve Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases