Clinical trial NCT04157530: Clinical Evaluation of Acupuncture in Treating Glaucoma
Official title: Clinical Evaluation of Acupuncture in Treating Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Acupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: intraocular pressure
timeFrame: 20 min, twice/week for 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Ching-Liang Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.