Clinical trial NCT06569810: Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
Official title: Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myopia
Repeated Low-level Red Light
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of fully controlled
timeFrame: 12 months for each participate
Secondary outcomes:
measure: BCVA changes
timeFrame: 12 months for each participate
measure: Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.)
timeFrame: 12 months for each participate
Other outcomes:
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