Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Single Arm Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 13
Healthy Volunteers: t
View:

• Provision of consent

• Non-Chinese Ethnicity

• Age: ≥8 and ≤13 years at enrollment

• Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)

⁃ 4\) Astigmatism of 2.50 D or less 5) Anisometropia of 1.50 D or less 6) Corrected monocular logMAR visual acuity (VA): 1.0 or better 7) Consent to participate in random allocation of grouping 8) Fluent in English 9) Willing and able to participate in all required activities of the study6) Corrected monocular logMAR visual acuity (VA): 1.0 or better

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Jonathan Li, MD
jonathan.li@ucsf.edu
4155143503
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2025-07-14
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: University of Melbourne

This content was sourced from clinicaltrials.gov