Primary Open Angle GlaucomaNCT05898997
Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure
A study testing Acupressure in people with Primary Open Angle Glaucoma and Acupressure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this clinical trial is to implement acupressure twice daily and monitor the changes in intraocular pressure (IOP) in patients with different levels of glaucoma. The study aims to investigate the effects of this method on IOP, visual field, retinal nerve fiber layer thickness measured by optical… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Acupressure
- What is being tested?
- Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2023to 25 Apr 2024
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary open-angle glaucoma, normal-tension glaucoma, and high intraocular pressure.
Who cannot join
- Patients with narrow-angle glaucoma, patients who have undergone eye surgery during the study period, patients who are unable to learn the acupoint massage procedure or unable to perform it regularly.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to implement acupressure twice daily and monitor the changes in intraocular pressure (IOP) in patients with different levels of glaucoma. The study aims to investigate the effects of this method on IOP, visual field, retinal nerve fiber layer thickness measured by optical coherence tomography, blood vessel density, and macular ganglion cell layer thickness and density in patients with primary open-angle glaucoma (POAG).
Read the detailed description
[Background] With the advancement of medical technology, many diseases can be controlled through Western medicine. However, there are still some diseases that cannot be effectively treated with Western medicine alone. Therefore, this article approaches the treatment of glaucoma from the perspective of traditional Chinese medicine meridians, by using acupressure to verify its effectiveness in reducing intraocular pressure in glaucoma patients.
[Participants] Between May 2023 and February 2024, a total of 80 patients were randomly selected from the ophthalmology outpatient clinic of National Taiwan University Hospital Hsinchu Branch. The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their intraocular pressure (IOP) levels.
The inclusion criteria were primary open-angle glaucoma and high IOP. Patients with angle-closure glaucoma, and those who had previously undergone eye surgery were excluded from the study.
[Materials and Methods] Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.
[Postoperative follow-up and evaluation] After one week, the best corrected visual acuity and changes in intraocular pressure will be followed up, and changes in intraocular pressure will be monitored regularly at 1 month, 3 months, 6 months, 9 months, and 12 months. Visual field testing and optical coherence tomography (OCT) will be monitored regularly at 6 months and 12 months.
[Data Statistics and Analysis] Record the subjects' intraocular pressure and visual acuity for statistical analysis. IBM SPSS v21.0 statistical software (IBM Corporation, New York, USA) will be used to calculate descriptive statistics, including mean ± standard deviation (±SD), median, range, and frequency and percentage as appropriate.
- Conditions
- Primary Open Angle Glaucoma, Acupressure
- Being tested
- Acupressure
- Keywords
- Primary Open Angle Glaucoma, High intraocular pressure, Acupressure, Bladder Meridian, Triple Burner Meridian
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
Also called Acupuncture point massage
Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Normal (Visual Field Defects: >-2.00 dB) | Experimental | Do the formal acupressure Receives: Behavioral: Acupressure |
| Mild (Visual Field Defects: -2.00~-6.00 dB) | Experimental | Do the formal acupressure Receives: Behavioral: Acupressure |
| Moderate (Visual Field Defects: -6.01~-12.00 dB) | Experimental | Do the formal acupressure Receives: Behavioral: Acupressure |
| Severe (Visual Field Defects: -12.01~-20.00dB) | Experimental | Do the formal acupressure Receives: Behavioral: Acupressure |
| Profound (Visual Field Defects: <-20 dB) | Experimental | Do the formal acupressure Receives: Behavioral: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure changes
Tracking the intraocular pressure changes in patients with different stages of glaucoma after undergoing acupoint massage
Measured: Monitored regularly at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.
Secondary outcomes (1)
Visual field testing by optical coherence tomography (OCT)
Tracking the changes of visual field testing by optical coherence tomography (OCT) in patients with different stages of glaucoma after undergoing acupoint massage
Measured: Monitored at 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Jun 2023
- Primary completion16 Apr 2024
- Study completion25 Apr 2024
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 National Taiwan 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their visual field defect levels.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898997
- Sponsor's protocol ID
- 202303119RINA
- Status last verified
- Apr 2024
- First submitted
- 2 Jun 2023
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Intraocular Pressure in Glaucoma Patients by Acupressure
- ClinicalTrials.gov ID
- NCT05898997
- Acronym / sponsor ID
- 202303119RINA
- Conditions
- Primary Open Angle Glaucoma, Acupressure
- Keywords
- Primary Open Angle Glaucoma, High intraocular pressure, Acupressure, Bladder Meridian, Triple Burner Meridian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 12 Jun 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.
The purpose of this clinical trial is to implement acupressure twice daily and monitor the changes in intraocular pressure (IOP) in patients with different levels of glaucoma. The study aims to investigate the effects of this method on IOP, visual field, retinal nerve fiber layer thickness measured by optical coherence tomography, blood vessel density, and macular ganglion cell layer thickness and density in patients with primary open-angle glaucoma (POAG).
Detailed description
[Background] With the advancement of medical technology, many diseases can be controlled through Western medicine. However, there are still some diseases that cannot be effectively treated with Western medicine alone. Therefore, this article approaches the treatment of glaucoma from the perspective of traditional Chinese medicine meridians, by using acupressure to verify its effectiveness in reducing intraocular pressure in glaucoma patients.
[Participants] Between May 2023 and February 2024, a total of 80 patients were randomly selected from the ophthalmology outpatient clinic of National Taiwan University Hospital Hsinchu Branch. The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their intraocular pressure (IOP) levels.
The inclusion criteria were primary open-angle glaucoma and high IOP. Patients with angle-closure glaucoma, and those who had previously undergone eye surgery were excluded from the study.
[Materials and Methods] Massage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening.
[Postoperative follow-up and evaluation] After one week, the best corrected visual acuity and changes in intraocular pressure will be followed up, and changes in intraocular pressure will be monitored regularly at 1 month, 3 months, 6 months, 9 months, and 12 months. Visual field testing and optical coherence tomography (OCT) will be monitored regularly at 6 months and 12 months.
[Data Statistics and Analysis] Record the subjects' intraocular pressure and visual acuity for statistical analysis. IBM SPSS v21.0 statistical software (IBM Corporation, New York, USA) will be used to calculate descriptive statistics, including mean ± standard deviation (±SD), median, range, and frequency and percentage as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The patients included in the study were between the ages of 15 and 80 and were classified into 5 groups based on their visual field defect levels.
| Arm | Type | Receives |
|---|---|---|
| Normal (Visual Field Defects: >-2.00 dB) | Experimental | Behavioral: AcupressureDo the formal acupressure |
| Mild (Visual Field Defects: -2.00~-6.00 dB) | Experimental | Behavioral: AcupressureDo the formal acupressure |
| Moderate (Visual Field Defects: -6.01~-12.00 dB) | Experimental | Behavioral: AcupressureDo the formal acupressure |
| Severe (Visual Field Defects: -12.01~-20.00dB) | Experimental | Behavioral: AcupressureDo the formal acupressure |
| Profound (Visual Field Defects: <-20 dB) | Experimental | Behavioral: AcupressureDo the formal acupressure |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with primary open-angle glaucoma, normal-tension glaucoma, and high intraocular pressure.
Key exclusion criteria (1 listed)
- Patients with narrow-angle glaucoma, patients who have undergone eye surgery during the study period, patients who are unable to learn the acupoint massage procedure or unable to perform it regularly.
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 |
|---|---|---|
| AcupressureAlso: Acupuncture point massageMassage the following acupoints in order: Jing Ming, Zan Zhu, Mei Chong, Yu Yao, and Si Zhu Kong. Use the joint of your thumb to massage each acupoint for 30 times, and repeat the cycle at least once. Then, continue to promote the circulation of qi by gently making a fist and using the four fingers to scrape along the upper eye socket from inside to outside. Scrape each side 30 times, and do it separately for the left and right sides. It is recommended to do this process at least once in the morning and once in the evening. | Behavioural | Mild (Visual Field Defects: -2.00~-6.00 dB), Moderate (Visual Field Defects: -6.01~-12.00 dB), Normal (Visual Field Defects: >-2.00 dB), Profound (Visual Field Defects: <-20 dB), Severe (Visual Field Defects: -12.01~-20.00dB) |
Primary outcome
Intraocular pressure changes
Time frame: Monitored regularly at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.
Tracking the intraocular pressure changes in patients with different stages of glaucoma after undergoing acupoint massage
1 secondary outcome
Visual field testing by optical coherence tomography (OCT)
Time frame: Monitored at 6 months and 12 months.
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 18 Jul 2024.
- Individual participant dataSharing planned: No. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Primary Open Angle Glaucoma and Acupressure, run by National Taiwan 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 1 inclusion and 1 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 18 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. 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?
Intraocular pressure changes (time frame: Monitored regularly at 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.). 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 18 Jul 2024.