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Completed

NCT Number: NCT04825769

Red Light Intervention for Myopia Prevention

To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangui He

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Students of grade 1-4 in the participating schools;
  • Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） >-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D <cycloplegic SE≤0.50D;
  • Students whose mother and/or father are in myopia status (SE < -3.0D for either of eyes);
  • Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.

Exclusion criteria

  • Students whose parents do not sign informed consent;
  • Students who have strabismus and/or other binocular vision abnormality;
  • Students who have other eye diseases and/or systematic diseases;
  • Students who have DC <=-1.5D;
  • Students whose difference of SE between the two eyes >=1.5D;
  • Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.

Treatment and study plan

LLLT（Low Level Laser Therapy）

Device

2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home

Primary outcomes

  1. One-year cumulative incidence of myopia (%) in the intervention group and the control group.

    Time frame: 1 year

    Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D

Secondary outcomes

  1. The progress of spherical equivalent(SE,D) of children in intervention group and control group.

    Time frame: 1 year

    The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon).

  2. The progress of axial length of children in intervention group and control group.

    Time frame: 1 year

    The axial length will be measured using IOLMaster.

  3. The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.

    Time frame: 1 year

    The choroidal thickness will be measured using SS-OCT.

  4. The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.

    Time frame: 1 year

    The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Sep 30, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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