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

Abducens Nerve Paralysis Clinical Trial

Official title:

A Retrospective Study to Investigate the Efficacy and Relative Factors of Ocular Acupuncture in Ocular Motor Nerve Palsy Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03461809
• Other study ID #: 20180204
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2018
• Last updated: March 5, 2018
• Start date: March 15, 2018
• Est. completion date: May 15, 2018

Study information

• Verified date: February 2018
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: lingyun zhou, PHD
• Phone: 85556000
• Email: no1zhly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abducens Nerve Paralysis
• Oculomotor Nerve Palsy
• Paralysis
• Trochlear Nerve Diseases
• Trochlear Nerve Palsy

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1 month.
Secondary	Diplopia angle	Patient's diplopia angle obtained by retrospective chart review.	Through study completion, an average of 2 weeks.
Secondary	Eyeball movement distance	Patient's eyeball movement distance obtained by retrospective chart review.	Through study completion, an average of 2 weeks.
Secondary	Distance between upper and lower eyelid.	Patient's distance between upper and lower eyelid obtained by retrospective chart review.	Through study completion, an average of 2 weeks.