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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Open-angle Glaucoma

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open-angle glaucoma diagnosis at least 3 months previously. Use of one or no intraocular hypotensive drugs. There is no evidence of other eye diseases other than glaucoma. Clear consciousness that enabled the participant to sign the informed consent form and cooperate with the trial procedure. Exclusion Criteria: Comorbidity with other chronic diseases, such as hypertension and diabetes, and taking multiple drugs. Laser surgery for either glaucoma or myopia. Pregnancy or lactation. Intolerance to acupuncture treatment. Allergy to acupuncture needles. Refusal to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham acupuncture group<br>Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks. | Device: Acupuncture<br>* 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.<br>|
| Experimental: Acupuncture group<br>Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks. | Device: Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | 24 weeks | 
| visual field |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | 24 weeks | 
| optic nerve fiber layer thickness |  | 24 weeks | 
| serum homocysteine concentration |  | 24 weeks | 
| WHOQOL-REF (Taiwan version) scale |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture