Red Light Intervention for Myopia Prevention

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: LLLT（Low Level Laser Therapy）

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Xiangui He

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Intervention; Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours	Device: LLLT（Low Level Laser Therapy）; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year cumulative incidence of myopia (%) in the intervention group and the control group.	Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The progress of spherical equivalent(SE,D) of children in intervention group and control group.	The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon).	1 year
The progress of axial length of children in intervention group and control group.	The axial length will be measured using IOLMaster.	1 year
The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.	The choroidal thickness will be measured using SS-OCT.	1 year
The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.	The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.	1 year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Director: Xiangui He, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Myopia; Prevention and control; Children and adolescents; Red light
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SHYB2021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No