Clinical Evaluation of Acupuncture in Treating Glaucoma

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

Tracking Information

• First Submitted Date: March 12, 2018
• First Posted Date: November 8, 2019
• Last Update Posted Date: November 8, 2019
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Evaluation of Acupuncture in Treating Glaucoma
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Glaucoma
• Acupuncture

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2019): 45
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 1, 2019
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04157530
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: China Medical University Hospital
• Study Sponsor: China Medical University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ching-Liang Hsieh, PhD; China Medical University, China

• PRS Account: China Medical University Hospital
• Verification Date: November 2019