Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration

NCT06264947 | Enrolling By Invitation

• 1 other identifier: CMUH112-REC2-141
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration

Keywords

Laser Acupuncture; Acupuncture; Age-related Macular Degeneration; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• 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.

  "baseline (pre-intervention)", and "immediately after the intervention"

Study Arms (2)

laser acupuncture group

EXPERIMENTAL

3 minutes for each time, and 3 times per week, with duration of 4 weeks

Device: laser acupuncture

sham laser acupuncture group

SHAM COMPARATOR

3 minutes for each time, and 3 times per week, with duration of 4 weeks

Device: sham laser acupuncture

Interventions

laser acupuncture DEVICE

wavelength: 808nm energy: 18j power: 100mw

laser acupuncture group

sham laser acupuncture DEVICE

wavelength: 0nm energy: 0j power: 0mw

sham laser acupuncture group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Yu-Chen Lee, M.D. & Ph.D.

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of acupuncture

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 20, 2024
• Study Start: January 26, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TW (1)