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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Randomized Controlled Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: Low-level Red Light Therapy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of consent 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 Anisometropia of 1.50 D or less Corrected monocular logMAR visual acuity (VA): 1.0 or better Consent to participate in random allocation of grouping Fluent in English Willing and able to participate in all required activities of the study Race/ethnicity is either African, Hispanic, or Caucasian. 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. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc. 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is a single-center, multi-ethnic, single-blind, parallel-group randomized controlled trial designed to evaluate the efficacy and safety of low level red light treatment on myopia among multi-ethnic schoolchildren.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Level Red Light Treatment Arm<br>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<br>* 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.<br>|
| No Intervention: Control Treatment Arm<br>Subjects in the control group will wear single vision spectacles. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia