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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

Tracking Information
First Submitted Date February 4, 2018
First Posted Date March 12, 2018
Last Update Posted Date March 12, 2018
Estimated Study Start Date March 15, 2018
Estimated Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 5, 2018)
  • Diplopia angle [ Time Frame: Through study completion, an average of 2 weeks. ]
    Patient's diplopia angle obtained by retrospective chart review.
  • Eyeball movement distance [ Time Frame: Through study completion, an average of 2 weeks. ]
    Patient's eyeball movement distance obtained by retrospective chart review.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Study of the Effects of Ocular Acupuncture on Ocular Motor Nerve Palsy
Official Title A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with ocular motor nerve palsy who received ocular acupuncture.
Condition
  • Oculomotor Nerve Palsy
  • Trochlear Nerve Palsy
  • Abducens Nerve Paralysis
Intervention 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.
Study Groups/Cohorts Ocular motor nerve palsy treated by ocular acupuncture
Ocular motor nerve palsy patients who received ocular acupuncture treatment
Intervention: Other: Ocular acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 5, 2018)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2018
Estimated Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: lingyun zhou, PHD 85556000 ext 3749 no1zhly@163.com
Contact: tiejuan liu, PHD 85556000 ext 5226 ltj850722@126.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03461809
Other Study ID Numbers 20180204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor First Affiliated Hospital of Harbin Medical University
Collaborators Not Provided
Investigators Not Provided
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date February 2018