Efficacy and Influencing Factors of Repeated Low-level Red-light in Myopia

NCT07104513 | Active Not Recruiting

• 1 other identifier: 2025KY-41
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the long-term efficacy of repeated low-level red-light (RLRL) therapy in the prevention and control of myopia in children, and to analyze the key factors influencing its efficacy (such as individual differences and compliance), with the aim of providing evidence-based support for the optimization of clinical myopia prevention and control strategies.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• axial length

  up to 72 months

Study Arms (4)

The RLRL-1year Group

use red light 1 year

Device: Red Light

The RLRL-2years Group

Device: Red Light

The RLRL-3years Group

Device: Red Light

The RLRL-more than 3 years

use the RLRL-more than 3 years

Device: Red Light

Interventions

Red Light DEVICE

use red light twice per day, both eyes. use red light for one year in The RLRL-1year Group. use red light for two year in The RLRL-2years Group. red light for three years in The RLRL-3years Group.red light for more than three years in The RLRL- more than 3years Group.

The RLRL-1year Group; The RLRL-2years Group; The RLRL-3years Group; The RLRL-more than 3 years

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

5-16 years old, 500

You may qualify if:

• Ages 5 to 16, gender unrestricted;
• RLRL device usage duration of one year or more.

You may not qualify if:

• Children with obvious strabismus and amblyopia
• With congenital eye disease, such as congenital cataract, congenital retinal disease
• Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
• Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
• Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
• Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg)
• Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
• Optic nerve damage or congenital optic nerve dysfunction
• Can not be regularly checked
• The adjustment range is less than 8D or obvious near difficulties

Sponsors & Collaborators

• Ruihua Wei: lead

Study Sites (2)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 120120, China

Location

Tianjin Medical University Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: September 28, 2020
• Primary Completion (Estimated): July 28, 2028
• Study Completion (Estimated): July 28, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)