Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments

This real-world observational registry study aims to assess the effectiveness of Repeated Low-Level Red Light (RLRL) therapy in controlling myopia progression among children aged 8 to 16 who have not responded to conventional treatments like Orthokeratology and atropine eyedrops. The primary focus is to determine if RLRL therapy can limit axial length (AL) elongation to less than 0.1mm per year and spherical equivalent refraction (SER) progression to less than 0.25 diopter per year, while also evaluating safety and visual outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Repeated Low-level Red Light
• Intervention / Treatment: Device: Repeated Low-Level Red Light (RLRL) therapy

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: MIngguang He, PhD; Phone Number: 85234002795; Email: mingguang.he@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The design of our study as a data registry project fundamentally shapes our approach to sample size estimation. Unlike traditional clinical trials, our study does not involve experimental interventions but instead collects real-world clinical data from patients on RLRL therapy. Consequently, our sample size will reflect the number of patients treated with RLRL in participating clinics during the study period. We anticipate significant uptake of this therapy, aiming to recruit up to 2,500 participants within one year, given its approval and present adoption in clinical practice. This estimated amount of participation is likely to provide a robust sample size, enhancing the statistical power and generalizability of our findings.

Description

Inclusion Criteria:

1. Age: 8 to 16 years at the time of data collection, aligning with the approved usage guidelines of the RLRL device.
2. Diagnosed with myopia and have been under conventional myopia treatments (include Orthokeratology, defocus incorporated multiple segments spectacles or equivalent, and 0.01% atropine or 0.05% atropine eyedrops) for at least six months. Eligible patient data must demonstrate insufficient control of myopia progression, defined as an axial elongation of 0.3 mm or more, or SER progression of 0.5 diopter or greater per year.
3. Best corrected visual acuity (BCVA): 20/20 or greater.
4. Data from patients who have utilized or are utilizing red light therapy as part of their myopia management strategy.

Exclusion Criteria:

1. Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.
2. Presence of systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.
3. Concurrent use of atropine eye drops and RLRL therapy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-responders to Conventional Treatments; This observational, real-world, web-based registry study will collect treatment data from multiple clinics of children aged 8-16 years old who have insufficient control of progression under myopia treatments for at least six months, and are receiving or intend to receive RLRL therapy. Insufficient control is defined as meeting either of the following criteria: AL elongation of less than 0.3mm per year or SER progression of 0.5 diopter (D) or greater per year. These subjects will then be defined as non-responders to conventional treatments for myopia, and offered RLRL therapy.

Device: Repeated Low-Level Red Light (RLRL) therapy; In our study, we do not implement any interventions; rather, we collect follow-up information from patients who, due to insufficient response to traditional myopia control therapies, have transitioned to Repeated Low-Level Red Light (RLRL) therapy. The data gathered will reflect treatment patterns as per the approved indications for RLRL therapy, where subjects may have undergone treatment sessions twice daily, each lasting for 3 minutes with a minimum interval of 4 hours between sessions. Our analysis will focus on the real-world outcomes, specifically evaluating the proportion of participants who have achieved effective myopia control (defined as AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year) after 12 months of documented RLRL therapy use among the collected data from eligible subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of fully controlled	The proportion of the people with AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year after RLRL therapy for 12 months.	12 months for each participate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA changes	Best corrected visual acuity (BCVA) changes at 12 months.	12 months for each participate
Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.)	Optical coherence tomography (OCT) scan changes at 12 months.	12 months for each participate

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HSEARS20240113001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No