Active, not recruitingNCT07104513RLRLUpdated Sep 8, 2025

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

An observational study in Myopia, sponsored by Ruihua Wei. Active, not recruiting at 2 sites in China. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Ruihua Wei · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 3,000
Ages: 5 Years to 16 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Myopia

Browse trials for

Myopia 980

Who can participate

Ages eligible: 5 Years to 16 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

5-16 years old, 500

Inclusion criteria

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

Exclusion criteria

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 3,000 participants (estimated)
Patient registry: No

Groups and cohorts

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

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.

What researchers measure

Primary outcomes

axial length
Time frame: up to 72 months

Study locations

2 sites

Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality 120120, China
Tianjin Medical University Eye Hospital
Tianjin, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07104513
Lead sponsor: Ruihua Wei
Responsible party: Ruihua Wei (Professor, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted: Aug 5, 2025
Start date: Sep 28, 2020
Primary completion: Jul 28, 2028 (estimated)
Completion: Jul 28, 2030 (estimated)
Last update: Sep 8, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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