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NCT Number: NCT07104513

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 5 to 16, gender unrestricted;
  • 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

Treatment and study plan

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.

Primary outcomes

  1. axial length

    Time frame: up to 72 months

Sponsors and collaborators

Lead sponsor

Ruihua Wei

Other

Registry information

Official study title

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

Acronym: RLRL

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Aug 5, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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