Red Light Intervention for Myopia Prevention

Sponsor
Shanghai Eye Disease Prevention and Treatment Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04825769
Collaborator
(none)
534
1
2
12
44.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LLLT(Low Level Laser Therapy)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
534 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Multicenter Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
Actual Study Start Date :
Mar 25, 2021
Anticipated Primary Completion Date :
Mar 25, 2022
Anticipated Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
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

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 meet the standards with which investigators and study physicians think it is not appropriate to enroll.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiangui He Shanghai Shanghai China 200040

Sponsors and Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier:
NCT04825769
Other Study ID Numbers:
  • SHYB2021001
First Posted:
Apr 1, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Eye Disease Prevention and Treatment Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021