Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repeated Low-Level Red Light (RLRL) therapy.
- Who it may be relevant to
- Registry conditions: Myopia, Repeated Low-level Red Light. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 a
Primary outcome measures
- The proportion of fully controlled [Time frame: 12 months for each participate]
Secondary outcome measures (2)
- BCVA changes [Time frame: 12 months for each participate]
- Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.) [Time frame: 12 months for each participate]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06569810 · HSEARS20240113001