NCT04722874

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Myopia, Progressive
• Refractive Errors
• Eye Diseases

Interventions

Type	Name	Description
DEVICE	Ortho-k lenses	Ortho-k lenses will be administered nightly.
DEVICE	RLRL	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.

Timeline

• Start date: 2021-03-14
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-01-25
• Last updated: 2021-08-13

Locations

3 sites across 1 country: China