Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06264947 |
| Other study ID # |
CMUH112-REC2-141 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 26, 2024 |
| Est. completion date |
November 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
China Medical University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
