Three-Month Interim Analyses of Repeated Low-Level Red-Light Therapy in Myopia Control in Schoolchildren: A Pilot Multi-Ethnic Randomized Controlled Trial
Deen N, Zhu Z, Qi Z, Aung YY, Bulloch G, Miao D, He M
Ophthalmic epidemiology · 3 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Sin clasificar
- Eyerising International
Según 1 financiador declarado.
Publicación
- Publicado
- 2025-05-19 · Ophthalmic Epidemiol · vol. 33 · número 3 · págs. 266–274
- Editorial
- Taylor & Francis
- Citado
- 9 citas · más que el 97% de estudios similares · 5.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 26 trabajos
- Acceso
- De pago
- Áreas de investigación
- Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Retinopathy of Prematurity Studies
- Palabras clave
- Medicine, Interim, Ethnic group, Randomized controlled trial, Physical therapy, Optometry, Pediatrics, Internal medicine
- MeSH
- humans, myopia, disease progression, refraction, ocular, treatment outcome, phototherapy, follow-up studies, pilot projects, eyeglasses, visual acuity, adolescent, child, female, male, axial length, eye, ethnicity
7 autores
- Nelofar Deen🇦🇺 · autor de correspondenciaAustralian College of Optometry
- Zhuoting Zhu
- Ziyi Qi🇦🇺Australian College of Optometry
- Yuri Yin‐Moe Aung
- Gabriella Bulloch🇦🇺The University of Melbourne
- Di Miao🇦🇺Australian College of Optometry
- Mingguang He🇭🇰Hong Kong Polytechnic University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in controlling myopia progression among multi-ethnic school-aged children. This report focuses on interim three-month data analysis.
Methods
A multi-ethnic, parallel controlled randomized trial. Thirty-four children aged 8-13 years with myopia were enrolled. Participants were randomly assigned to the RLRL group (n = 17) or the single-vision spectacles (SVS) control group (n = 17). RLRL therapy was administered twice daily on weekdays for three-minute sessions, while the SVS group continued routine activities. Assessments were scheduled at baseline and follow-up visits at one, three, six and 12 months, with compliance monitoring and safety assessments throughout. Respectively the primary outcome and a key secondary outcome are axial length (AL) change and cycloplegic spherical equivalent (SE) change.
Results
A total of 32 (94.1%) participated in the three-month follow-up visit. The RLRL group demonstrated a significant shortening in AL ( - 0.06 ± 0.05 mm) compared to the SVS group (0.02 ± 0.06 mm, p < 0.001). Similarly, the RLRL group demonstrated a reversal in SE (0.23 ± 0.18 D), whereas the SVS group exhibited a smaller increase (0.04 ± 0.43 D). No severe adverse events were reported in either of the groups.
Conclusions
The three-month interim analysis shows that RLRL therapy effectively controls myopia progression among multi-ethnic children without safety concerns, suggesting its potential as a globally applicable solution for myopia control.
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