Recruiting

Low-level Red-light Therapy

Sponsor:

UCLA

Code:

NCT05606237

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

Interventions

Low-level Red Light Therapy Device

Study Details

Brief 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.

Conditions

Myopia

Study ID

NCT05606237

Start date

Jul 14, 2023

Status verified date

Jan, 2026

Completion date

Jan 14, 2027

Anticipated

Primary completion date

Jan 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Provision of consent
2. Non-Chinese Ethnicity
3. Age: ≥8 and ≤13 years at enrollment
4. 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

Exclusion Criteria:

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Low-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.

Primary outcome measure

  • Axial Length (AL) (mm) at Baseline [ Time Frame: 1 month ]
  • Axial Length (AL) (mm) at Month 1 [ Time Frame: 1 month ]
  • Axial Length (AL) (mm) at Month 3 [ Time Frame: 3 months ]
  • Axial Length (AL) (mm) at Month 6 [ Time Frame: 6 months ]
  • Axial Length (AL) (mm) at Year 1 [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Tiffany Chen, MD

4155143503Tiffany.A.Chen@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jenny Lu

415-476-5321jenny.lu@ucsf.edu

Principal Investigator:

Tiffany Chen, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • myopia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-28.