GlaucomaNCT05753137
Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
A study testing Acupuncture in people with Glaucoma and Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Acupuncture, Intraocular Pressure
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2023to 27 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open angle glaucoma diagnosed at least 3 months ago.
- Diagnosed with mild or moderate open angel glaucoma.
- Use 1 or 2 kinds of glaucoma drugs.
- Age ≥ 20 years old.
- Participants sign the informed consent and cooperate with the experimental procedures.
Who cannot join
- Accept any ophthalmic laser or surgery within one year.
- High myopia.
- Use of any drugs that affect intraocular pressure.
- Visual acuity with correction lower than 0.2.
- Previous or existing uveitis or retinopathy.
- Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
- Pregnancy or breastfeeding.
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Lee Yu-Chen, Ph.D, +886-975-682-023, d5167@mail.cmuh.org.tw
About this study
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.
Read the detailed description
This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.
- Conditions
- Glaucoma, Acupuncture, Intraocular Pressure
- Being tested
- Acupuncture, Acupuncture placebo
- Keywords
- Glaucoma, Acupuncture
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The treatment will take place once a week, over six weeks. The needles will placed in the body for 20 minutes. A total of 12 Needles(6 acupoints, bilaterally) will be used in each session.Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation.
Acupuncture placeboOther
A total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.The control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation.
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic Acupoint Treatment Group | Experimental | Ophthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints. Receives: Other: Acupuncture |
| Non-ophthalmological Acupoint Control Group | Placebo comparator | Non-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related pathologies, and are not reported to improve ophthalmological function. Receives: Other: Acupuncture placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure-pre-treatment
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Measured: Every weeks pre-acupuncture treatment up to six weeks.
Intraocular pressure-after-treatment
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Measured: Every weeks 15 minutes after acupuncture treatment up to six weeks.
Intraocular pressure-Change
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
Measured: Change from baseline intraocular pressure at 12 weeks.
Secondary outcomes (11)
Optical coherence tomography-RNFL symmety
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. RNFL symmety and Retinal nerve fiber layer (RNFL) thickness measurements obtained with Optical coherence tomography employs low-coherence interferometry.The unit of value is %.
Measured: Change from baseline RNFL symmety at 12 weeks.
Optical coherence tomography-C/D ratio
The optic disk and the RNFL are the principal sites of apparent glaucomatous damage which precedes glaucomatous visual field alterations. The cup/disc (C/D) ratio as a standardised method to evaluate the optic nerve obtained with Optical coherence tomography employs low-coherence interferometry.
Measured: Change from baseline C/D ratio at 12 weeks.
Optical coherence tomography angiography-RPC density
Optical coherence tomography angiography is a relatively new, non-invasive, dye-free imaging modality that provides a qualitative and quantitative assessment of the vasculature in the retina and optic nerve head. We use OCTA to complement visual field and OCT examinations to diagnose glaucoma, detect progression and evaluate the treatment of acupuncture. Using OCT angiograms, the RPC density was evaluated quantitatively. The unit of value is %.
Measured: Change from baseline RPC density at 6 weeks.
Central corneal thickness
To measure mean values of central corneal thickness (CCT) obtained by specular microscopy.
Measured: On the first and 12th week for baseline and follow up tracing.
Glaucoma Symptom Scale
The Glaucoma Symptom Scale (GSS) is a simple and brief glaucoma-specific questionnaire aimed at quantifying complaints and functional impairment in patients with glaucoma. We used 1998 version of the Glaucoma Symptom Scale (GSS; Lee et al., 1998) Questionnaire.The items include 10 ocular complaints, for each eye, a 5-level score is generated, ranging from 0 (complaint present and very bothersome) to 4 (complaint absent). This score is then transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem.
Measured: On the first and 12th week for baseline and follow up tracing.
Glaucoma Quality of Life - 15
The GQL-15 questionnaire is composed of 15 items. A 5-point rating scale for the level of difficulty of each task totals a score from 0 to 75. A higher score signifies a poorer .
Measured: On the first and 12th week for baseline and follow up tracing.
Blood pressure
We measure the blood pressure of patient before and after acupuncture treatment .Both systolic and diastolic blood pressure will be measured.
Measured: we measure blood pressure every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
Heart rate
We measure the heart rate of patient before and after acupuncture treatment .
Measured: we measure heart rate every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
Best corrected visual acuity
Best possible vision a an eye can see with corrective lenses, measured in terms of Snellen lines.
Measured: Change from baseline best corrected visual acuity at 12 weeks.
Visual field- mean deviation
The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry.The unit of value is dB.
Measured: Change from baseline visual field at 12 weeks.
Visual field- visual field index
The visual field refers to the total area in which objects can be seen in the side (peripheral) vision as you focus your eyes on a central point. Visual field will measured with automated perimetry. Visual field index intuitive presentation may underestimate the visual loss.
Measured: Change from baseline visual field at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start28 Jun 2023
- Primary completion27 Jun 2025 (estimated)
- Study completion27 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEE YU-CHEN, Ph.D, Study director, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753137
- Sponsor's protocol ID
- CMUH111-REC3-210
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.
PubMed 28577860Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
PubMed 8695555Quigley HA, Vitale S. Models of open-angle glaucoma prevalence and incidence in the United States. Invest Ophthalmol Vis Sci. 1997 Jan;38(1):83-91.
PubMed 9008633Liao YF, Lee YC, Lin HJ, Shao YC. Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 8;13:e57888. doi: 10.2196/57888.
PubMed 39378079
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05753137
- Acronym / sponsor ID
- CMUH111-REC3-210
- Conditions
- Glaucoma, Acupuncture, Intraocular Pressure
- Keywords
- Glaucoma, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 27 Jun 2025 (estimated)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 3 Mar 2023 (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.
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.
Detailed description
This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic Acupoint Treatment Group | Experimental | Other: AcupunctureOphthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time. Acupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints. |
| Non-ophthalmological Acupoint Control Group | Placebo comparator | Other: Acupuncture placeboNon-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time. Acupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related pathologies, and are not reported to improve ophthalmological function. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary open angle glaucoma diagnosed at least 3 months ago.
- Diagnosed with mild or moderate open angel glaucoma.
- Use 1 or 2 kinds of glaucoma drugs.
- Age ≥ 20 years old.
- Participants sign the informed consent and cooperate with the experimental procedures.
Key exclusion criteria (8 listed)
- Accept any ophthalmic laser or surgery within one year.
- High myopia.
- Use of any drugs that affect intraocular pressure.
- Visual acuity with correction lower than 0.2.
- Previous or existing uveitis or retinopathy.
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 treatment will take place once a week, over six weeks. The needles will placed in the body for 20 minutes. A total of 12 Needles(6 acupoints, bilaterally) will be used in each session.Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. | Other | Ophthalmic Acupoint Treatment Group |
| Acupuncture placeboA total of 12 Needles(6 acupoints, bilaterally) will be used in each session. Acupuncture points are different from the experimental group.The control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. | Other | Non-ophthalmological Acupoint Control Group |
Primary outcome
Intraocular pressure-pre-treatment
Time frame: Every weeks pre-acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-after-treatment
Time frame: Every weeks 15 minutes after acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-Change
Time frame: Change from baseline intraocular pressure at 12 weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
11 secondary outcomes
Optical coherence tomography-RNFL symmety
Time frame: Change from baseline RNFL symmety at 12 weeks.
Optical coherence tomography-C/D ratio
Time frame: Change from baseline C/D ratio at 12 weeks.
Optical coherence tomography angiography-RPC density
Time frame: Change from baseline RPC density at 6 weeks.
Central corneal thickness
Time frame: On the first and 12th week for baseline and follow up tracing.
Glaucoma Symptom Scale
Time frame: On the first and 12th week for baseline and follow up tracing.
Glaucoma Quality of Life - 15
Time frame: On the first and 12th week for baseline and follow up tracing.
Blood pressure
Time frame: we measure blood pressure every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
Heart rate
Time frame: we measure heart rate every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.
Best corrected visual acuity
Time frame: Change from baseline best corrected visual acuity at 12 weeks.
Visual field- mean deviation
Time frame: Change from baseline visual field at 12 weeks.
Visual field- visual field index
Time frame: Change from baseline visual field at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Results publication: PubMed 28577860Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.
- Results publication: PubMed 8695555Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
- Results publication: PubMed 9008633Quigley HA, Vitale S. Models of open-angle glaucoma prevalence and incidence in the United States. Invest Ophthalmol Vis Sci. 1997 Jan;38(1):83-91.
- Derived from this study: PubMed 39378079Liao YF, Lee YC, Lin HJ, Shao YC. Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 8;13:e57888. doi: 10.2196/57888.
- 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.
LEE YU-CHEN, Ph.D study director
China Medical University, China
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 Glaucoma and Acupuncture, 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LEE YU-CHEN, Ph.D (886-4-22052121 ext. 1670, d5167@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure-pre-treatment (time frame: Every weeks pre-acupuncture treatment up to six weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753137, which also lists 4 linked publications.
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 3 Jul 2024.