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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors Repeated Low-level Red Light

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: 8 to 16 years at the time of data collection, aligning with the approved usage guidelines of the RLRL device.
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.
Best corrected visual acuity (BCVA): 20/20 or greater.
Data from patients who have utilized or are utilizing red light therapy as part of their myopia management strategy.

Exclusion criteria

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

Treatment and study plan

Repeated Low-Level Red Light (RLRL) therapy

Device

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.

Primary outcomes

The proportion of fully controlled

Time frame: 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 outcomes

BCVA changes

Time frame: 12 months for each participate

Best corrected visual acuity (BCVA) changes at 12 months.
Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.)

Time frame: 12 months for each participate

Optical coherence tomography (OCT) scan changes at 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

MIngguang He, PhD

CONTACT

[email protected]

85234002795

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Aug 26, 2024
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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