Myopia, Repeated Low-level Red Light
Conditions
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.
Interventions
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| BCVA changes | 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.) | 12 months for each participate | Optical coherence tomography (OCT) scan changes at 12 months. |
Contacts
Primary ContactMIngguang He, PhD
Outcome results
None listed