Status:
NOT_YET_RECRUITING
Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Myopia
Repeated Low-level Red Light
Eligibility:
All Genders
8-16 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06569810
Start Date
September 1 2024
End Date
September 1 2026
Last Update
August 26 2024
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