Age-related Macular DegenerationNCT06264947
Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration
A study testing laser acupuncture in people with Age-related Macular Degeneration, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jan 2024to 1 Nov 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who have been diagnosed with dry-AMD
- Male or female patients above 20 years of age at the screening visit
- Those who voluntarily signed the informed consent
Who cannot join
- Those who refuse to sign the consent form
- Pregnant women
- Individuals with epilepsy
- Patients with angina
- Individuals with hyperthyroidism
- Patients with a cardiac pacemaker
- Those who applied immunosuppressive agents containing Arsenic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Laser Acupuncture on Zanzhu (BL02) as the Treatment for Dry Age-related Macular Degeneration: A Randomized Controlled Trial
This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again.
Read the detailed description
This study consists of 15 visits, which are divided into the screening period and the treatment period.
Screening visit After being provided with sufficient information for this study, the patient would voluntarily sign the informed consent. The patients who have submitted the informed consent will undergo screening tests to determine their eligibility. The screening tests include general medical history taking, treatment history for AMD, vision test. Based on the eligibility criteria and screening tests, identification codes would be granted to eligible participants.
Visit 1 Visit 1 will be arranged within a week from the screening visit. The participants who have successfully completed the screening visit can proceed to visit 1 on the same day. The participant's changes in medical history and medication taking since the screening visit will be surveyed. Randomization will be performed on the eligible participants. Before implementing each intervention, examinations would be conducted to measure outcomes, BCVA. The participants would be educated according to the assigned intervention. The experimental group would receive laser acupuncture treatment, and the control group would receive the sham laser acupuncture. In both group, any discomfort or adverse events (AEs) before and after the treatment would be surveyed. Some observation items, including vital signs, vision test, medical history, medication taking, participant's compliance, discomfort before and after the treatment and AEs, will be examined every visit. Participant teaching would also be conducted during every visit.
Visits 2-12 During visits 2-12, the observation items will be examined including visual acuity, medical history, medication taking, discomfort before and after the treatment and AEs since the last visit. Both group would visit three times a week for 4 weeks. At each visit, the experimental group would receive the laser acupuncture treatment, and the control group would receive the sham laser acupuncture. In both group, discomfort before and after the treatment would be surveyed.
Visit 13 Visit 13 will be arranged within 3 days, after a 4-week period has elapsed since visit 1. (If 4 hours have elapsed since the treatment of visit 12, visit 13 could be arranged on the same day as visit 12.) For both group, a survey would be conducted to check any changes related to medical history, medication taking and AEs since visit 12. Vision test will be conducted. When the assessments have finished, treatment satisfaction will be evaluated.
Visit 14 Visit 14 will be arranged within 3 days, after a 6-week period has elapsed since visit 1. Any changes in medical history, medication taking and AEs since visit 13 will be surveyed. Final assessments for vision test will be conducted. Lastly, the participants' final compliance will be investigated.
Additional visits Additional visits can be arranged on the participants' request or if the investigators deem them necessary. Additional follow-ups for the appeared AEs could also be arranged. They would be permitted if the AEs continue until the trial is fully completed or stopped early, or if the investigators or the participants request additional follow-ups after finishing the treatment.
- Conditions
- Age-related Macular Degeneration
- Being tested
- laser acupuncture, sham laser acupuncture
- Keywords
- Laser Acupuncture, Acupuncture, Age-related Macular Degeneration, Randomized Controlled Trials
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
wavelength: 808nm energy: 18j power: 100mw
sham laser acupunctureDevice
wavelength: 0nm energy: 0j power: 0mw
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture group | Experimental | 3 minutes for each time, and 3 times per week, with duration of 4 weeks Receives: Device: laser acupuncture |
| sham laser acupuncture group | Sham comparator | 3 minutes for each time, and 3 times per week, with duration of 4 weeks Receives: Device: sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA (Best Corrected Visual Acuity)
BCVA is the best possible vision an eye can see with corrective lenses. The gold standard for measuring BCVA is with the Early Treatment Diabetic Retinopathy (ETDRS) chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m). If fewer than 20 letters can be read at 4m, the patient's position is adjusted to 1m in front of the chart.
Measured: "baseline (pre-intervention)", and "immediately after the intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start26 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
- Investigators
- Yu-Chen Lee, M.D. & Ph.D., Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264947
- Sponsor's protocol ID
- CMUH112-REC2-141
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Acupuncture on Zanzhu (BL02) as the Treatment for Dry Age-related Macular Degeneration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06264947
- Acronym / sponsor ID
- CMUH112-REC2-141
- Conditions
- Age-related Macular Degeneration
- Keywords
- Laser Acupuncture, Acupuncture, Age-related Macular Degeneration, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 20 Feb 2024 (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 study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again.
Detailed description
This study consists of 15 visits, which are divided into the screening period and the treatment period.
Screening visit After being provided with sufficient information for this study, the patient would voluntarily sign the informed consent. The patients who have submitted the informed consent will undergo screening tests to determine their eligibility. The screening tests include general medical history taking, treatment history for AMD, vision test. Based on the eligibility criteria and screening tests, identification codes would be granted to eligible participants.
Visit 1 Visit 1 will be arranged within a week from the screening visit. The participants who have successfully completed the screening visit can proceed to visit 1 on the same day. The participant's changes in medical history and medication taking since the screening visit will be surveyed. Randomization will be performed on the eligible participants. Before implementing each intervention, examinations would be conducted to measure outcomes, BCVA. The participants would be educated according to the assigned intervention. The experimental group would receive laser acupuncture treatment, and the control group would receive the sham laser acupuncture. In both group, any discomfort or adverse events (AEs) before and after the treatment would be surveyed. Some observation items, including vital signs, vision test, medical history, medication taking, participant's compliance, discomfort before and after the treatment and AEs, will be examined every visit. Participant teaching would also be conducted during every visit.
Visits 2-12 During visits 2-12, the observation items will be examined including visual acuity, medical history, medication taking, discomfort before and after the treatment and AEs since the last visit. Both group would visit three times a week for 4 weeks. At each visit, the experimental group would receive the laser acupuncture treatment, and the control group would receive the sham laser acupuncture. In both group, discomfort before and after the treatment would be surveyed.
Visit 13 Visit 13 will be arranged within 3 days, after a 4-week period has elapsed since visit 1. (If 4 hours have elapsed since the treatment of visit 12, visit 13 could be arranged on the same day as visit 12.) For both group, a survey would be conducted to check any changes related to medical history, medication taking and AEs since visit 12. Vision test will be conducted. When the assessments have finished, treatment satisfaction will be evaluated.
Visit 14 Visit 14 will be arranged within 3 days, after a 6-week period has elapsed since visit 1. Any changes in medical history, medication taking and AEs since visit 13 will be surveyed. Final assessments for vision test will be conducted. Lastly, the participants' final compliance will be investigated.
Additional visits Additional visits can be arranged on the participants' request or if the investigators deem them necessary. Additional follow-ups for the appeared AEs could also be arranged. They would be permitted if the AEs continue until the trial is fully completed or stopped early, or if the investigators or the participants request additional follow-ups after finishing the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture group | Experimental | Device: laser acupuncture3 minutes for each time, and 3 times per week, with duration of 4 weeks |
| sham laser acupuncture group | Sham comparator | Device: sham laser acupuncture3 minutes for each time, and 3 times per week, with duration of 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who have been diagnosed with dry-AMD
- Male or female patients above 20 years of age at the screening visit
- Those who voluntarily signed the informed consent
Key exclusion criteria (7 listed)
- Those who refuse to sign the consent form
- Pregnant women
- Individuals with epilepsy
- Patients with angina
- Individuals with hyperthyroidism
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 |
|---|---|---|
| laser acupuncturewavelength: 808nm energy: 18j power: 100mw | Device | laser acupuncture group |
| sham laser acupuncturewavelength: 0nm energy: 0j power: 0mw | Device | sham laser acupuncture group |
Primary outcome
BCVA (Best Corrected Visual Acuity)
Time frame: "baseline (pre-intervention)", and "immediately after the intervention"
BCVA is the best possible vision an eye can see with corrective lenses. The gold standard for measuring BCVA is with the Early Treatment Diabetic Retinopathy (ETDRS) chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m). If fewer than 20 letters can be read at 4m, the patient's position is adjusted to 1m in front of the chart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
Yu-Chen Lee, M.D. & Ph.D. study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture in people with Age-related Macular Degeneration, 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 3 inclusion and 7 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 20 Feb 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?
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?
BCVA (Best Corrected Visual Acuity) (time frame: "baseline (pre-intervention)", and "immediately after the intervention"). 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 20 Feb 2024.