Efficacy of Repeated Low-level Red-light Therapy in Myopia Control

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05606237
Status
Recruiting
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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Low-level Red Light Therapy Device — DEVICE
    The treatment device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.

Study Details

Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Key Dates

Start date
Jul 14, 2023
Status verified
Jan 2026
Primary completion
Jan 14, 2027
Completion
Jan 14, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low Level Red Light Treatment Arm
    On top of wearing single vision spectacles, subjects in the intervention group will receive low-level red light treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours.

Primary Outcome Measure

Axial Length (AL) (mm) at Baseline [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Jenny Lu
[email protected]
415-476-5321
Tiffany Chen, MD (PRINCIPAL_INVESTIGATOR)
Ying Han, MD/PhD (SUB_INVESTIGATOR)

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