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NCT Number: NCT05606237

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jenny Lu

CONTACT

[email protected]

415-476-5321

Tiffany Chen, MD

PRINCIPAL_INVESTIGATOR

Ying Han, MD/PhD

SUB_INVESTIGATOR

About this study

The purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in African, Hispanic, and Caucasian children. This is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. On top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. Subjects in the control group will wear single vision spectacles. The study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. The study plans to conduct an interim analysis at a three-month follow-up. The enrollment target is 90 participants: 30 Hispanic Children (15 control and 15 treatment) , 30 African Children (15 control and 15 treatment), and 30 Caucasian Children (15 control and 15 treatment).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Axial Length (AL) (mm) at Baseline

    Time frame: 1 month

    Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

  2. Axial Length (AL) (mm) at Month 1

    Time frame: 1 month

    Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

  3. Axial Length (AL) (mm) at Month 3

    Time frame: 3 months

    Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

  4. Axial Length (AL) (mm) at Month 6

    Time frame: 6 months

    Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

  5. Axial Length (AL) (mm) at Year 1

    Time frame: 1 Year

    Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Chen, MD

CONTACT

[email protected]

4155143503

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of Melbourne

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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