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Effectiveness and Safety of Repeated Low-Level Red-Light Therapy on Myopia Control Among Children and Adolescents

NCT05871840 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2023-06-22

No results posted yet for this study

Summary

Myopia has become one of the leading causes of visual impairment globally and brings a heavy burden on the society. Therefore, preventing and controlling the progression of myopia has become an urgent public health issue that needs to be addressed.

The purpose of this study is to provide real-world evidence for identifying the incidence of myopia control (axial length growth rate ≤ 0.1mm/year) after 36-month RLRL therapy, and long-term safety of RLRL therapy in children and adolescents.

Conditions

  • Myopia

Interventions

OTHER

Repeated Low-Level Red-Light (RLRL) Therapy

This treatment device was made by Eyerising SuzhouXuanjia Optoelectronics Technology, which has been on the market and used widely for amblyopia treatment for the past decade in China. This device is certified as a class IIa device by the China National Medical Products Administration. It consists of semiconductor laser diodes, which deliver low-level red light with a wavelength of 650 ±10 nm at an illuminance level of approximately 1600 lux through the pupil to the fundus. Based on calculations completed by an independent lab, the light power going through a 4-mm pupil is 0.29 mW and is classified as class 1 under the International Electrotechnical Commission 60825-1:2014 standard, which is at a level considered safe for direct ocular exposure that would not create retinal thermal hazard.

Sponsors & Collaborators

  • the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China

    collaborator UNKNOWN

  • First Hospital Affiliated to Baotou Medical College, Baotou, China

    collaborator UNKNOWN

  • Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences

    lead OTHER

Principal Investigators

  • Fang Yu · Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-06-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871840 on ClinicalTrials.gov