Clinical trial NCT03099447: Effects of Ocular Electroacupuncture on Oculomotor Nerve Palsy
Official title: A Randomized Trial of Ocular Electroacupuncture for Oculomotor Nerve Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oculomotor Nerve Palsy
Keywords: electroacupuncture
oculomotor nerve palsy
rehabilitation
diplopia
ocular motility disorder
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Ocular motor nerve function subscale at 6 Weeks
timeFrame: 6 week
Secondary outcomes:
measure: Angle of diplopia deviation
timeFrame: 6 week
measure: Eyeball movement distance
timeFrame: 6 week
measure: The quality of life questionnaire for ocular motor nerve palsy
timeFrame: 6 week
Other outcomes:
Locations:
city: Harbin Shi
country: China
facility: The first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Lingyun Zhou, PhD
role: STUDY_CHAIR
References: