NCT04825769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

March 24, 2021

Last Update Submit

September 28, 2022

Conditions

Myopia

Keywords

Children and adolescentsMyopiaPrevention and controlRed light

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    1 year

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

    1 year

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

    1 year

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

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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）

Control

NO INTERVENTION

No intervention

Interventions

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

Intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangui He

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

  • He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, Chen J, Yang J, Du L, Niu C, Leng M, Huang J, Liu K, Zou H, He M, Xu X. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239612. doi: 10.1001/jamanetworkopen.2023.9612.

    PMID: 37099298DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Xiangui He

    Shanghai Eye Disease Prevention and Treatment Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 1, 2021

Study Start

March 25, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)