Red Light Intervention for Myopia Prevention

Myopia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825769
• Other study ID #: SHYB2021001
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
China	Xiangui He	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The progress of axial length of children in intervention group and control group.	The axial length will be measured using IOLMaster.	1 year
Secondary	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
Secondary	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