Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial
Xiong R, Wang W, Tang X, He M, Hu Y, Zhang J, Du B, Jiang Y, Zhu Z, Chen Y, Zhang S, Kong X, Wei R, Yang X, He M
Ophthalmology · 34 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
- Universidad u hospital
- Hong Kong Polytechnic University
- Universidad u hospital
- Guangdong Provincial People's Hospital
- Gobierno
- Basic and Applied Basic Research Foundation of Guangdong Province
- Universidad u hospital
- Guangdong Provincial People's Hospital Affiliated to Southern Medical University
- Subvenciones
- Basic and Applied Basic Research Foundation of Guangdong Province (2019B1515120011)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2024-05-17 · Ophthalmology · vol. 131 · número 11 · págs. 1304–1313
- Editorial
- Elsevier BV
- Citado
- 47 citas · más que el 99% de estudios similares · 12.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- De pago
- Áreas de investigación
- Ophthalmology and Visual Impairment Studies · Ocular and Laser Science Research · Laser Applications in Dentistry and Medicine
- Palabras clave
- myopia control, orthokeratology, low-level red light therapy, axial elongation, axial length change, children, myopia progression, orthokeratology lenses, visual acuity, treatment safety, adverse events, low-level laser therapy, combination therapy, cycloplegic refraction, uncorrected visual acuity
- MeSH
- humans, myopia, refraction, ocular, treatment outcome, combined modality therapy, phototherapy, follow-up studies, single-blind method, visual acuity, adolescent, child, female, male, orthokeratologic procedures, axial length, eye
17 autores
- Ruilin XiongState Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Wei WangState Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Xianghua TangState Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Meinan He🇭🇰🇨🇳 · autor de correspondenciaHong Kong Polytechnic University; Sun Yat-sen University; Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
- Yin Hu🇭🇰🇨🇳Hong Kong Polytechnic University; Sun Yat-sen University; Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
- Yin HuState Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Jian Zhang🇨🇳Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
- Bei Du🇨🇳Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University; South China University of Technology
- Jiang Yu🇨🇳🇦🇺Sun Yat-sen University; The Royal Victorian Eye & Ear Hospital; Centre for Eye Research Australia; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; South China University of Technology
- Zhuoting Zhu🇨🇳🇦🇺Sun Yat-sen University; The Royal Victorian Eye & Ear Hospital; Centre for Eye Research Australia; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Yanping ChenState Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Shiran Zhang🇨🇳Foshan Second People's Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Xiangbin Kong🇨🇳Foshan Second People's Hospital; Tianjin Medical University Eye Hospital; Tianjin Medical University
- Ruihua Wei🇨🇳Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
- Xiao ke Yang🇭🇰Hong Kong Polytechnic University; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University
- Mingguang He🇭🇰🇨🇳Hong Kong Polytechnic University; Sun Yat-sen University; Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
- Mingguang He🇭🇰🇨🇳 · autor de correspondenciaHong Kong Polytechnic University; Sun Yat-sen University; Tianjin Medical University Eye Hospital; State Key Laboratory of Ophthalmology; Zhongshan Ophthalmic Center, Sun Yat-sen University; Tianjin Medical University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
To investigate the efficacy and safety of repeated low-level red-light (RLRL) therapy combined with orthokeratology among children who, despite undergoing orthokeratology, exhibited an axial elongation of at least 0.50 mm over 1 year.
Design
Multicenter, randomized, parallel-group, single-blind clinical trial (ClinicaTrials.gov identifier, NCT04722874).
Participants
Eligible children were 8-13 years of age with a cycloplegic spherical equivalent refraction of -1.00 to -5.00 diopters at the initial orthokeratology fitting examination and had annual axial length (AL) elongation of ≥0.50 mm despite undergoing orthokeratology. Forty-eight children were enrolled from March 2021 through January 2022, and the final follow-up was completed in March 2023.
Methods
Children were assigned randomly to the RLRL therapy combined with orthokeratology (RCO) group or to the orthokeratology group in a 2:1 ratio. The orthokeratology group wore orthokeratology lenses for at least 8 hours per night, whereas the RCO group received daily RLRL therapy twice daily for 3 minutes in addition to orthokeratology.
Main outcome measures
The primary outcome was AL change measured at 12 months relative to baseline. The primary analysis was conducted in children who received the assigned intervention and completed at least 1 follow-up after randomization using the modified intention-to-treat principle.
Results
Forty-seven children (97.9%) were included in the analysis (30 in the RCO group and 17 in the orthokeratology group). The mean axial elongation rate before the trial was 0.60 mm/year and 0.61 mm/year in the RCO and orthokeratology groups, respectively. After 12 months, the adjusted mean AL changes were -0.02 mm (95% confidence interval [CI], -0.08 to +0.03 mm) in the RCO group and 0.27 mm (95% CI, 0.19-0.34 mm) in the orthokeratology group. The adjusted mean difference in AL change was -0.29 mm (95% CI, -0.44 to -0.14 mm) between the groups. The percentage of children achieving an uncorrected visual acuity of more than 20/25 was similar in the RCO (64.3%) and orthokeratology (65.5%) groups (P = 0.937).
Conclusions
Combining RLRL therapy with orthokeratology may offer a promising approach to optimize axial elongation control among children with myopia. This approach also potentially allows children to achieve satisfactory visual acuity, reducing daytime dependence on corrective eyewear.
Financial disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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