A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
Phase: NA
Conditions: Myopia
Sponsor: Shanghai Eye Disease Prevention and Treatment Center

NCT number: [2021]075
A multicenter randomized controlled
trial of low-dose single-wavelength red
light in the decrease of myopia incidence
rate in the setting of school
Shanghai Eye Disease Prevention and Treatment Center
March 27, 2021

A multicenter randomized controlled trial of low-dose single-wavelength red light in the
decrease of myopia incidence rate in the setting of school.
Study aims and rationales
A multicenter randomized controlled trial exploring the effectiveness of
low-dose single-wavelength red light on the prevention of myopia and the
decrease of myopia incidence rate in children of grade 1-4 of primary
schools (age of 6-12 years).
Primary aim
To examine the effectiveness of low-dose single-wavelength red light on
the prevention of myopia and the decrease of myopia incidence rate in the
setting of school.
Secondary aim
To examine the effect of low-dose single-wavelength red light on
spherical equivalent (SE) and uncorrected visual acuity in school-aged
children who are in pro-myopia status.
Study design
A multicenter randomized controlled trail.
Study participants and estimated
enrollment
Primary school students of grade 1-4 who are in pro-myopia status will be
enrolled as study participants.
Inclusion criteria
1.
Students of grade 1-4 in the participating schools;
2.
Students who are in pro-myopia status, as defined as cycloplegic SE
between -0.5D(exclusive) and 0.5D (inclusive);
3.
Students whose mother and/or father are in myopia status (SE≤-3.0D
for either of eyes);
4.
Students whose parents sign informed consent and agree to let their
kids participate in study.
Exclusion criteria
1.
Students whose parents do not sign informed consent;
2.
Students who have strabismus and/or other binocular vision
abnormality;
3.
Students who have other eye diseases and/or systematic diseases
4.
Students who meet the standards with which investigators and study
physicians think it is not appropriate to enroll.
Sample size
A total of 534 students will be included in the study, half of which(267) in
the intervention group and half in the control group
Arrangement for baseline and
follow-up ophthalmic
examinations
Baseline ophthalmic examinations will be conducted in March 2021; a
total of three times of follow-ups will be administered in June, September
and December 2021; end-point examinations will be conducted in march
2022.
Trial duration
Thetrialwilllast12monthsstartingfromthebaselineinMarch2021totheendpointin
March2022.
Intervention
Intervention
group
Theenrolled studentswillbefirststratifiedaccordingtogradewithineachofthe
participatingschools;withineachofthestratifiedgrade,thestudents willbe
randomlyassignedina ratioof1:1toeitherthe interventiongrouporthecontrol
group.
Participantsintheinterventiongroupwillreceive low-dosesingle-wavelengthred
lightinterventioninthesettingofschoolfromthefirstdaytothefifthdayofthe
week;onsummaryandwintervocations,the participantswillreceiveintervention
athomeeveryday.

Theinterventionlasts threeminutesonetime,twotimes a day, theintervalbetween
twoexposuresina dayshouldbemorethan4 hours.
Control group
Participants in the control group will not receive the intervention.
Primary outcome
The cumulative incidence rate of myopia among intervention and control
groups.
Statistical hypothesis
The intervention of low-dose single-wavelength red light can prevent
myopia and decrease the incidence rate of myopia.
Key words
School-aged children, low-dose single-wavelength red light, prevention of
myopia.
Supplementary information
None.