Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264947
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2024-02-06
Brief Title:
Efficacy of Laser Acupuncture on Zanzhu BL02 for Dry Age-related Macular Degeneration
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Efficacy of Laser Acupuncture on Zanzhu BL02 as the Treatment for Dry Age-related Macular Degeneration A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 participants 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 participants 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
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 participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None