RecruitingNot ApplicableNCT05606237

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

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

Sponsor

University of California, San Francisco

Enrollment

90 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Myopia

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

Min Age: 8 YearsMax Age: 13 Years

Inclusion Criteria5

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)
\) 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

Exclusion Criteria5

Strabismus and binocular vision abnormalities in either eye
Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.
Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment
Noncompliance with treatment
Children whose parents do not sign informed consent

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Interventions

DEVICELow-level Red Light Therapy 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.