An observational study in Myopia and Repeated Low-level Red Light, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by The Hong Kong Polytechnic University · Observational
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 150 across 173 observational studies indexed under Myopia.
Browse Myopia studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
This observational, real-world, web-based registry study will collect treatment data from multiple clinics of children aged 8-16 years old who have insufficient control of progression under myopia treatments for at least six months, and are receiving or intend to receive RLRL therapy. Insufficient control is defined as meeting either of the following criteria: AL elongation of less than 0.3mm per year or SER progression of 0.5 diopter (D) or greater per year. These subjects will then be defined as non-responders to conventional treatments for myopia, and offered RLRL therapy.
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 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.
The proportion of fully controlled
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.
Time frame: 12 months for each participate
BCVA changes
Best corrected visual acuity (BCVA) changes at 12 months.
Time frame: 12 months for each participate
Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.)
Optical coherence tomography (OCT) scan changes at 12 months.
Time frame: 12 months for each participate
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University