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

• Sponsor: China Medical University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05247762
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Device: Acupuncture	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
• Anticipated Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. visual acuity [24 weeks]

2. visual field [24 weeks]

Secondary Outcome Measures

1. intraocular pressure [24 weeks]

2. optic nerve fiber layer thickness [24 weeks]

3. serum homocysteine concentration [24 weeks]

4. WHOQOL-REF (Taiwan version) scale [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China Medical University Hospital	Taichung	North District	Taiwan	40447

Sponsors and Collaborators

• China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT05247762
• Other Study ID Numbers: CMUH110-REC2-225
• First Posted: Feb 21, 2022
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China Medical University Hospital: Acupuncture
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Feb 21, 2022