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

Not yet recruiting

• Conditions: Myopia; Repeated Low-level Red Light
• Interventions: Device: Repeated Low-Level Red Light (RLRL) therapy

• Registration Number: NCT06569810
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-09-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-responders to Conventional Treatments	Repeated Low-Level Red Light (RLRL) therapy	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.

Primary Outcome Measures

Name	Time	Method
The proportion of fully controlled	12 months for each participate	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.

Secondary Outcome Measures

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