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

NCT05606237 | Recruiting DMC FDA Device

• 1 other identifier: 21-35793
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

myopia

Outcome Measures

Primary Outcomes (5)

• Axial Length (AL) (mm) at Baseline

  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.

  1 month

• Axial Length (AL) (mm) at Month 1

  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.

  1 month

• Axial Length (AL) (mm) at Month 3

  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 months

• Axial Length (AL) (mm) at Month 6

  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.

  6 months

• Axial Length (AL) (mm) at Year 1

  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.

  1 Year

Study Arms (1)

Low Level Red Light Treatment Arm

EXPERIMENTAL

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.

Device: Low-level Red Light Therapy Device

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.

Low Level Red Light Treatment Arm

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Melbourne: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (1)

• Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

  PMID: 26875007 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Tiffany Chen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Chen, MD

CONTACT

4155143503; Tiffany.A.Chen@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a single-center, multi-ethnic, single-blind, single arm controlled trial designed to evaluate the efficacy and safety of low level red light treatment on myopia among multi-ethnic schoolchildren.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: November 4, 2022
• Study Start: July 14, 2023
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis.

Locations

US (1)