Primary Open-angle GlaucomaNCT05247762
Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
A study testing Acupuncture in people with Primary Open-angle Glaucoma, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Feb 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Acupuncture
- Keywords
- Acupuncture
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham acupuncture group | Sham comparator | Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks. Receives: Device: Acupuncture |
| Acupuncture group | Experimental | Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Primary outcome measure was the changes of visual acuity
Measured: 24 weeks
visual field
Primary outcome measure was the changes of visual field
Measured: 24 weeks
Secondary outcomes (4)
intraocular pressure
Secondary outcome measure was the changes of intraocular pressure
Measured: 24 weeks
optic nerve fiber layer thickness
Secondary outcome measure was the changes of optic nerve fiber layer thickness
Measured: 24 weeks
serum homocysteine concentration
Secondary outcome measure was the changes of serum homocysteine concentration
Measured: 24 weeks
the World Health Organization Quality of Life brief (Taiwan version) scale
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start28 Feb 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Liang Hsieh, Ph.D, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247762
- Sponsor's protocol ID
- CMUH110-REC2-225
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT05247762
- Acronym / sponsor ID
- CMUH110-REC2-225
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham acupuncture group | Sham comparator | Device: AcupunctureUse Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks. |
| Acupuncture group | Experimental | Device: AcupunctureUse stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Device | Acupuncture group, Sham acupuncture group |
Primary outcome
visual acuity
Time frame: 24 weeks
Primary outcome measure was the changes of visual acuity
visual field
Time frame: 24 weeks
Primary outcome measure was the changes of visual field
4 secondary outcomes
intraocular pressure
Time frame: 24 weeks
optic nerve fiber layer thickness
Time frame: 24 weeks
serum homocysteine concentration
Time frame: 24 weeks
the World Health Organization Quality of Life brief (Taiwan version) scale
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Liang Hsieh, Ph.D principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Primary Open-angle Glaucoma, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.