Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control

Study Overview
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Brief Summary
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The purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (RLRL) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.

Detailed Description
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Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. However, results after ortho-k treatment vary among individuals. Methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Our previous clinical study suggested RLRL could effectively retard myopia progression without clinically observable side effects. The purpose of this study is to evaluate the adjunctive effect of RLRL and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. Ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. The subjects will be randomly assigned to either experimental group (RLRL and ortho-k) or control group (ortho-k). Their axial length will be monitored over one year. Changes in axial length in the two groups will be compared.

Official Title
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The Multicenter Randomized Clinical Trial of Fast-progressing Myopia Control Using Repeated Low-Level Red-Light Therapy and Orthokeratology

Conditions
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Myopia, Progressive, Refractive Errors, Eye Diseases

Intervention / Treatment
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* Device: Ortho-k lenses
* Device: RLRL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Start to receive ortho-k treatment one year ago. Age at enrolment: 8-13 years. Ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye. Before wearing ortho-k lenses, spherical equivalent refractions (SERs) ranging from -1.00 to -5.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D, and best corrected logMAR visual acuity (VA) equal to or better than 0 in both eyes. Parents' understanding and acceptance of random allocation of grouping Exclusion Criteria: Strabismus and binocular vision abnormalities. Ocular or systemic abnormalities. Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc. Other contraindications.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ortho-k<br>Participants will continue to use ortho-k lenses alone. | Device: Ortho-k lenses<br>* Ortho-k lenses will be administered nightly.<br>* Other names: Orthokeratology lens;|
| Experimental: RLRL+Ortho-k<br>Participants will be treated with RLRL twice a day in addition to ortho-k lenses. | Device: Ortho-k lenses<br>* Ortho-k lenses will be administered nightly.<br>* Other names: Orthokeratology lens;Device: RLRL<br>* RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.<br>* Other names: Repeated low-level red-light therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length change | Axial length change (mm) is characterized as the difference between 12-month follow-up visit and baseline values. The Lenstar is used to measure axial length (mm). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other ocular parameters | The Lenstar is used to measure ocular parameters (e.g., cornea thickness, lens thickness). Change of each parameter is characterized as the difference between its 12-month follow-up visit and baseline values. | 12 months | 
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over the study period for subjects in both arms. | 12 months |