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Clinical Evaluation of Acupuncture in Treating Glaucoma

Primary Purpose

Glaucoma, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
wang-bu-liu-xing
acupuncture
Electroacupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Glaucoma for at least three months
  2. Do not use ocular hypotensive drugs or use only one ocular hypotensive drug.
  3. It is over 20 years old.
  4. Men and women are informal.
  5. There is no evidence other than glaucoma that shows other eye diseases.
  6. Be aware and fill out the consent form yourself.

Exclusion Criteria:

  1. Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc.
  2. Those who have had glaucoma surgery.
  3. Those who had undergone myopia laser surgery.
  4. Can not accept acupuncture points stimulators.
  5. Allergic to acupuncture needles.
  6. Has a mental illness or is unable to cooperate with the researcher.
  7. Do not sign consent

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

sham group

acupuncture group

Electroacupuncture group

Arm Description

15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi

15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi

Outcomes

Primary Outcome Measures

intraocular pressure
Primary outcome measure was the changes of intraocular pressure,

Secondary Outcome Measures

Full Information

First Posted
March 12, 2018
Last Updated
November 7, 2019
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04157530
Brief Title
Clinical Evaluation of Acupuncture in Treating Glaucoma
Official Title
Clinical Evaluation of Acupuncture in Treating Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.
Detailed Description
Glaucoma is a syndrome, and that is results from intraocular pressure increases cause visual field narrow and blindness. The incidence of adult blindness induced by glaucoma is second in the ophthalmologic disease in the world. Many studies report that both blood circulation in the eye surroundings and intraocular pressure increase play an important role in glaucoma. Several studies show that acupuncture can modulate intraocular pressure and improve activity of central visual acuity and also increase blood flow of eye fundus. Jingming (BL1) can communicate yi and yang, and nourish and clear eyes, Qiuhou (EX-HN7) can transport qi and activate blood, and freely flowing meridian and clear eyes. Therefore, the purpose of the present study was to investigate the therapeutic effect of acupuncture at Jinming and Qiuhou on intraocular pressure in patients with glaucoma. The study designed as a single-blinded, randomized, controlled clinical trial, a total of45 patients with glaucoma divided into three groups, each group was15 subjects as follows: 1) sham group, using the seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints, one times/day, and each time was 20 min, twice/week for 2 weeks; 2) acupuncture group, the methods were identical to the sham group, but used acupuncture applied to Qingming and Qiuhou with Der-qi; 3) Electroacupuncture group, the methods were identical to acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch. Primary outcome measure was the changes of intraocular pressure, and the second outcome measure was the score changes of WHOQOL-REF (Taiwan version). The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi
Arm Title
Electroacupuncture group
Arm Type
Experimental
Arm Description
15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi
Intervention Type
Device
Intervention Name(s)
wang-bu-liu-xing
Other Intervention Name(s)
Canon Pneumotonometer
Intervention Description
wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
acupuncture applied to Qingming and Qiuhou with Der-qi
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Intervention Description
acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch
Primary Outcome Measure Information:
Title
intraocular pressure
Description
Primary outcome measure was the changes of intraocular pressure,
Time Frame
20 min, twice/week for 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Glaucoma for at least three months Do not use ocular hypotensive drugs or use only one ocular hypotensive drug. It is over 20 years old. Men and women are informal. There is no evidence other than glaucoma that shows other eye diseases. Be aware and fill out the consent form yourself. Exclusion Criteria: Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc. Those who have had glaucoma surgery. Those who had undergone myopia laser surgery. Can not accept acupuncture points stimulators. Allergic to acupuncture needles. Has a mental illness or is unable to cooperate with the researcher. Do not sign consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26310164
Citation
Mac Nair CE, Nickells RW. Neuroinflammation in Glaucoma and Optic Nerve Damage. Prog Mol Biol Transl Sci. 2015;134:343-63. doi: 10.1016/bs.pmbts.2015.06.010. Epub 2015 Jul 10.
Results Reference
result
PubMed Identifier
32419820
Citation
Chen SY, Yieh FS, Liao WL, Li TC, Hsieh CL. Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 28;2020:7208081. doi: 10.1155/2020/7208081. eCollection 2020.
Results Reference
derived

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Clinical Evaluation of Acupuncture in Treating Glaucoma

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