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

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Device: Low-level Red Light Therapy Device

• Registration Number: NCT05606237
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-04
• Study Start: 2023-07-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-07-14
• Study Completion: 2025-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Level Red Light Treatment Arm	Low-level Red Light Therapy Device	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.

Primary Outcome Measures

Name	Time	Method
Axial Length (AL) (mm) at Baseline	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.
Axial Length (AL) (mm) at Month 1	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.
Axial Length (AL) (mm) at Month 6	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.
Axial Length (AL) (mm) at Month 3	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.
Axial Length (AL) (mm) at Year 1	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States