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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03099447
Other study ID # 2017030801
Secondary ID
Status Recruiting
Phase N/A
First received March 24, 2017
Last updated March 28, 2017
Start date April 6, 2017
Est. completion date July 25, 2019

Study information

Verified date March 2017
Source First Affiliated Hospital of Harbin Medical University
Contact LingYun Zhou, PhD
Phone +86 13351113936
Email no1zhly@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to testify the efficacy of treating oculomotor nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.


Description:

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for oculomotor nerve palsy (ONP), through treating ONP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by oculomotor nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.


Recruitment information / eligibility

Status Recruiting
Enrollment 177
Est. completion date July 25, 2019
Est. primary completion date March 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion criteria;

1. patient with confirmed diagnosis of complete oculomotor nerve palsy (with or without mydriasis) made by neurologist or ophthalmologist;

2. patient in stable condition after treatment for primary disease;

3. age between 18 to 80 years old without gender limitation;

4. haven't received acupuncture intervention for ONP before;

5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to ONP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;

2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;

3. those with serious medical conditions that might limit their participation;

4. those with eye or other location with serious infections;

5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;

6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;

7. who had participate in other clinical trials, which may affect the results.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ocular electroacupuncture
During intervention period, patients will continue to keep medications for primary condition. 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.
ocular acupuncture
During intervention period, patients will continue to keep medications for primary condition. 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 duration of intervention is 40 minutes.
sham acupuncture
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.

Locations

Country Name City State
China The first affiliated hospital of Harbin Medical University Harbin Shi Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Ocular motor nerve function subscale at 6 Weeks The patient will receive grading of eyelid lifting, eyeball inward, upward and downward moving ability by investigator. A total score will be summed up.The changes from baseline will be recorded. 6 week
Secondary Angle of diplopia deviation Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. 6 week
Secondary Eyeball movement distance The distances of eyeball movement in inward, upward and downward direction and height between eyelids will be measured. The differences between affected and healthy eye will be calculated. 6 week
Secondary The quality of life questionnaire for ocular motor nerve palsy The patients will finish a questionnaire to evaluate their physical and psychological status during this trial. 6 week
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03461809 - A Retrospective Study of the Effects of Ocular Acupuncture on Ocular Motor Nerve Palsy N/A