Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma

Not Applicable

Completed

• Conditions: Primary Open-angle Glaucoma
• Interventions: Device: Acupuncture

• Registration Number: NCT05247762
• Lead Sponsor: China Medical University Hospital

Brief Summary

The goal of this clinical trial is to test the therapeutic effect of acupuncture at the Jingming and the Qiuhou acupoints on the visual acuity and visual field in patients with primary open-angle glaucoma.

Participants will get acupuncture or Wangbuliu Xingzi Paste (sham acupuncture) on both sides of the Jingming and the Qiuhou, once a week, once for 20 minutes, for 24 weeks.

Researchers will compare acupuncture group and sham acupuncture group to see if the visual acuity, visual field, intraocular pressure, optic nerve fiber layer thickness, serum homocysteine concentration, and scores on the WHOQOL-REF (Taiwan version) scale would be improved.

Detailed Description

Glaucoma is a syndrome. The long-term increase in intraocular pressure eventually leads to visual field defect and blindness. Lowering the intraocular pressure in patients with glaucoma is considered to be the most effective way to treat glaucoma. Many studies believe that both blood circulation around the eyes and increased intraocular pressure play a critical role in glaucoma. Some studies have shown that acupuncture can adjust intraocular pressure and improve optic nerve activity, as well as increase blood flow of the eye fundus. Jingming (BL1) can communicate yin and yang, nourish and improve eyesight, and Qiuhou (EX-HN7) can promote qi and blood circulation, and improve vision. The results of our previous research found that acupuncture or electroacupuncture can reduce the intraocular pressure in patients with glaucoma. Therefore, the purpose of this study is to assess the therapeutic effect of acupuncture at the Jingming and the Qiuhou acupoints on the visual acuity and visual field in patients with primary open-angle glaucoma. This study designed a randomized, single-blind, controlled clinical trial. A total of 40 patients with primary open-angle glaucoma were randomly divided into two groups equally as follows: 1) Sham acupuncture group: Only use Wangbuliu Xingzi Paste on the skin on the acupoints on both sides of the Jingming and the Qiuhou, once a week, once for 20 minutes, for 24 weeks; 2) Acupuncture group: The method is the same as the sham acupuncture group, but the stainless steel needles are used to insert into the two points of Jingming and the Qiuhou, and der-qi, once a week, once for 20 minutes, for 24 consecutive weeks. The main assessment is visual acuity and visual field; the secondary assessment includes intraocular pressure, optic nerve fiber layer thickness, serum homocysteine concentration, and changes in scores on the WHOQOL-REF (Taiwan version) scale.

It is expected that acupuncture intervention can improve the visual acuity and visual field in patients with glaucoma.

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Study Start: 2022-02-28
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Open-angle glaucoma diagnosis at least 3 months previously.
2. Use of one or no intraocular hypotensive drugs.
3. There is no evidence of other eye diseases other than glaucoma.
4. Clear consciousness that enabled the participant to sign the informed consent form and cooperate with the trial procedure.

Exclusion Criteria

1. Comorbidity with other chronic diseases, such as hypertension and diabetes, and taking multiple drugs.
2. Laser surgery for either glaucoma or myopia.
3. Pregnancy or lactation.
4. Intolerance to acupuncture treatment.
5. Allergy to acupuncture needles.
6. Refusal to sign the informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture	Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.
Sham acupuncture group	Acupuncture	Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.

Primary Outcome Measures

Name	Time	Method
visual acuity	24 weeks	Primary outcome measure was the changes of visual acuity
visual field	24 weeks	Primary outcome measure was the changes of visual field

Secondary Outcome Measures

Name	Time	Method
the World Health Organization Quality of Life brief (Taiwan version) scale	24 weeks	Secondary outcome measure was the changes of the World Health Organization Quality of Life brief (Taiwan version) scale. The score is between 0-140, and higher score means better life quality.
intraocular pressure	24 weeks	Secondary outcome measure was the changes of intraocular pressure
optic nerve fiber layer thickness	24 weeks	Secondary outcome measure was the changes of optic nerve fiber layer thickness
serum homocysteine concentration	24 weeks	Secondary outcome measure was the changes of serum homocysteine concentration

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, North District, Taiwan