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

NCT ID: NCT05247762

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-11-30

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.

Conditions

Primary Open-angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sham acupuncture group

Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.

Group Type: SHAM_COMPARATOR

Acupuncture

Intervention Type: DEVICE

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.

Acupuncture group

Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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.

Interventions

Acupuncture

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Liang Hsieh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

China Medical University Hospital

Taichung, North District, Taiwan

Countries

Taiwan

Other Identifiers

CMUH110-REC2-225

Identifier Type: -

Identifier Source: org_study_id