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

NCT05871840 | Unknown

• 1 other identifier: LL-KT-2023006-X1
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence of myopia control after 36-month RLRL therapy

  Validity index: myopia control was defined as axial length growth rate ≤ 0.1mm/year

  36 months or more

Secondary Outcomes (8)

• Incident visual impairment (logMAR visual acuity < 0.8)

  6-12 months, 12-24 months, 24-36 months, 36 months or more

• Incident structural damage of the retina and choroid

  6-12 months, 12-24 months, 24-36 months, 36 months or more

• Change of axial length per year after RLRL therapy.

  6-12 months, 12-24 months, 24-36 months, 36 months or more

• Change of spherical equivalent refraction per year after RLRL therapy

  6-12 months, 12-24 months, 24-36 months, 36 months or more

• The incidence of myopia control after 6-,12- and 24-month RLRL therapy

  6-12 months, 12-24 months, 24-36 months

Study Arms (4)

Treatment duration of RLRL therapy (≥ 6 months and < 12 months)

Other: Repeated Low-Level Red-Light (RLRL) Therapy

Treatment duration of RLRL therapy (≥12 months and < 24 months)

Other: Repeated Low-Level Red-Light (RLRL) Therapy

Treatment duration of RLRL therapy (≥24 months and < 36 months)

Other: Repeated Low-Level Red-Light (RLRL) Therapy

Treatment duration of RLRL therapy (≥36 months)

Other: Repeated Low-Level Red-Light (RLRL) Therapy

Interventions

Repeated Low-Level Red-Light (RLRL) Therapy OTHER

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.

Treatment duration of RLRL therapy (≥ 6 months and < 12 months); Treatment duration of RLRL therapy (≥12 months and < 24 months); Treatment duration of RLRL therapy (≥24 months and < 36 months); Treatment duration of RLRL therapy (≥36 months)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

In this study, the investigators aim to recruit 360 participants aged 7-18 years at 3 study centers from 3 tertiary hospitals in China, stratified by the treatment duration of RLRL therapy including 6 to 12 months (\<12 months); 12 to 24 months (\< 24 months); 24 to 36 months (\< 36 months); and 36 months or more. Thirty participants are recruited at each treatment duration for each study center. Therefore, the minimum number of subjects per study center is 30, and the maximum number of subjects per study center is 120.

You may qualify if:

• Aged 7-18 years old
• Myopia of cycloplegic spherical equivalent refraction (SER) of -1.0D or greater in both of eyes before starting RLRL therapy
• Participants undergo RLRL therapy currently
• With complete examination data before starting RLRL therapy, including visual acuity, axial length and cycloplegic spherical equivalence refraction
• The subject and their guardian voluntarily sign the informed consent form

You may not qualify if:

• Presence of strabismus, binocular vision abnormalities, other ocular abnormalities in either eye
• Secondary myopia (such as myopia caused by retinopathy of prematurity or other eye diseases in infancy or early childhood) or myopia associated with systemic syndromes (such as Marfan syndrome)
• Presence of other significant ocular and/or systemic diseases or abnormalities
• Medical history of previous eye surgery, laser treatment, or intravitreal injection and so on
• Participants if investigators believe they have contraindications that make them unsuitable for participation.

Sponsors & Collaborators

• Shenzhen Hospital (Guangming), University of Chinese Academy of Sciences: lead
• the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China: collaborator
• First Hospital Affiliated to Baotou Medical College, Baotou, China: collaborator

Related Publications (1)

• Chen Y, Wang W, Xiong R, Yu F, Pan S, Dong J, Zhang J, Zhu Z, Ding X, Wang B, Chen Y, Chan HH, Choi KY, Chan SSH, Zheng Y, Shi D, Aung Y, Kishi S, Ohno-Matsui K, He M. Three-year efficacy and safety of repeated low-level red-light therapy for myopia control: a multicentre real-world study. Br J Ophthalmol. 2026 Jan 20:bjo-2025-328687. doi: 10.1136/bjo-2025-328687. Online ahead of print.

  PMID: 41558834 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Fang Yu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiong Jiping

CONTACT

18126081918; 377721053@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 23, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share