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Clinical Evaluation of Acupuncture in Treating Glaucoma

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ClinicalTrials.gov Identifier: NCT04157530
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
intraocular pressure [ Time Frame: 20 min, twice/week for 2 weeks ]
Primary outcome measure was the changes of intraocular pressure,
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Acupuncture in Treating Glaucoma
Official Title  ICMJE Clinical Evaluation of Acupuncture in Treating Glaucoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Acupuncture
Intervention  ICMJE
  • Device: wang-bu-liu-xing
    wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
    Other Name: Canon Pneumotonometer
  • Device: acupuncture
    acupuncture applied to Qingming and Qiuhou with Der-qi
  • Device: Electroacupuncture
    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
Study Arms  ICMJE
  • Sham Comparator: sham group
    15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
    Intervention: Device: wang-bu-liu-xing
  • Experimental: acupuncture group
    15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi
    Intervention: Device: acupuncture
  • Experimental: Electroacupuncture group
    15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi
    Intervention: Device: Electroacupuncture
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2019)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157530
Other Study ID Numbers  ICMJE CMUH106-REC2-161
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ching-Liang Hsieh, PhD China Medical University, China
PRS Account China Medical University Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP