Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
Primary Purpose
Primary Open-angle Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Acupuncture
Eligibility Criteria
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.
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham acupuncture group
Acupuncture group
Arm Description
Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.
Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.
Outcomes
Primary Outcome Measures
visual acuity
visual field
Secondary Outcome Measures
intraocular pressure
optic nerve fiber layer thickness
serum homocysteine concentration
WHOQOL-REF (Taiwan version) scale
Full Information
NCT ID
NCT05247762
First Posted
February 10, 2022
Last Updated
February 10, 2022
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05247762
Brief Title
Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
Official Title
Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma
Keywords
Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham acupuncture group
Arm Type
Sham Comparator
Arm Description
Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.
Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual acuity
Time Frame
24 weeks
Title
visual field
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
intraocular pressure
Time Frame
24 weeks
Title
optic nerve fiber layer thickness
Time Frame
24 weeks
Title
serum homocysteine concentration
Time Frame
24 weeks
Title
WHOQOL-REF (Taiwan version) scale
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
North District
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, Ph.D
Phone
+886-4-22053366
Ext
3127
Email
clhsieh@mail.cmuh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
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