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

March 5, 2018 updated by: First Affiliated Hospital of Harbin Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: lingyun zhou, PHD
  • Phone Number: 3749 85556000
  • Email: no1zhly@163.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with ocular motor nerve palsy who received ocular acupuncture.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diplopia angle
Time Frame: Through study completion, an average of 2 weeks.
Patient's diplopia angle obtained by retrospective chart review.
Through study completion, an average of 2 weeks.
Eyeball movement distance
Time Frame: Through study completion, an average of 2 weeks.
Patient's eyeball movement distance obtained by retrospective chart review.
Through study completion, an average of 2 weeks.
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.
Through study completion, an average of 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2018

Primary Completion (Anticipated)

May 15, 2018

Study Completion (Anticipated)

May 15, 2018

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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