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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04157530
Other study ID # CMUH106-REC2-161
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date November 1, 2019

Study information

Verified date November 2019
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
wang-bu-liu-xing
wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
acupuncture
acupuncture applied to Qingming and Qiuhou with Der-qi
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

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary intraocular pressure Primary outcome measure was the changes of intraocular pressure, 20 min, twice/week for 2 weeks
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