BACKGROUND
Age-related macular degeneration (AMD), including dry-AMD and wet-AMD, is a common cause of blindness in the elderly population (above 60). However, there has not been effective treatment for dry-AMD so far. Traditional Chinese Medicine (TCM) acupuncture, practiced for over 2500 years in China, has gained popularity in Western countries as a complementary therapy. Also, a meta-analysis conducted by our team in 2023 shows that acupuncture is significantly more effective than interventions of the control groups, and that the most frequently selected acupuncture points in the literature, excluding those with incomplete data, were Jingming (BL01) and Zanzhu (BL02). As traditional needle acupuncture is invasive, lowering patients’ willingness to undergo the treatment, Jingming (BL01) is contraindicated for laser acupuncture to prevent eye injury due to its location, we suggest further investigation into the efficacy of laser acupuncture on Zanzhu (BL02).
OBJECTIVE
The primary objective of this study is to determine whether the experimental group (laser acupuncture) exhibits a greater average change in Best Corrected Visual Acuity (BCVA) in comparison to the control group (sham laser acupuncture).
METHODS
This study is a single-center, investigator-initiated, assessor-blinded, parallel randomized controlled trial. 30 participants would be enrolled. This study consists of 15 visits, which are divided into 1 screening visit, 12 treatment visits, and 2 survey visits in chronological order. Over the 12 treatment visits in 4 weeks, both groups would receive interventions three times a week. Laser acupuncture with the wave of 808nm and the output power of 100mw would be performed on bilateral BL02 for 3 min. On the other hand, the control group would receive sham laser acupuncture with the wave of 0nm and the output power of 0mw on the same acupoints for 3 min. The frequency of interventions would be recorded during the trial. The primary outcomes are Best Corrected Visual Acuity (BCVA). The outcomes would be mostly assessed at visits 1, 13 and 14. All data would be analyzed with SPSS Statistics V.21 after completely collected.
RESULTS
This study was approved by the institutional review board of China Medical University Hospital (Approval No. CMUH112-REC2-141). The first participant was enrolled on 25 January 2024. Participant recruitment has not been complete so far. The obtained results would be disseminated through publication in a peer-reviewed journal.
CONCLUSIONS
Based on our samples and with the parameters and methods used, we can observe the efficacy of BCVA change provided by laser acupuncture at 808 nm in comparison with that of the control group.
CLINICALTRIAL
This study was registered on the ClinicalTrials.gov on 17 February 2024. (Registration No. NCT06264947)