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Red Light Intervention for Myopia Prevention

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LLLT（Low Level Laser Therapy）
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Children and adolescents, Myopia, Prevention and control, Red light

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangui He

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
The progress of axial length of children in intervention group and control group.
The axial length will be measured using IOLMaster.
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.
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.

Full Information

First Posted
March 24, 2021
Last Updated
September 28, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT04825769
Brief Title
Red Light Intervention for Myopia Prevention
Official Title
A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Children and adolescents, Myopia, Prevention and control, Red light

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
LLLT（Low Level Laser Therapy）
Intervention Description
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 Outcome Measure Information:
Title
One-year cumulative incidence of myopia (%) in the intervention group and the control group.
Description
Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The progress of spherical equivalent(SE,D) of children in intervention group and control group.
Description
The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon).
Time Frame
1 year
Title
The progress of axial length of children in intervention group and control group.
Description
The axial length will be measured using IOLMaster.
Time Frame
1 year
Title
The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.
Description
The choroidal thickness will be measured using SS-OCT.
Time Frame
1 year
Title
The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.
Description
The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangui He
Organizational Affiliation
Shanghai Eye Disease Prevention and Treatment Center
Official's Role
Study Director
Facility Information:
Facility Name
Xiangui He
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Red Light Intervention for Myopia Prevention

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