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

Study on the Long-term Efficacy Evaluation and Influencing Factors of Repeated Low-level Red-light Therapy in Myopia Prevention and Control in Children

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07104513

Acronym

RLRL

Enrollment

3000

Registered

2025-08-05

Start date

2020-09-28

Completion date

2030-07-28

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Detailed description

This is a real world multi-centre study. The devices are connected to the internet with an automated diary function to record treatment sessions and to monitor patient compliance.The total sample size of 3000 arerandomly allocated into treatment groups,observation for 1 year and more.

Interventions

DEVICERed Light

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

Healthy volunteers

Yes

Inclusion criteria

1. Ages 5 to 16, gender unrestricted; 2. RLRL device usage duration of one year or more.

Exclusion criteria

* 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 * Other reasons researchers think it is not suitable for inclusion in researchers

Design outcomes

Primary

Measure	Time frame
axial length	up to 72 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026