Red Light Intervention for Myopia Prevention

Shanghai Eye Disease Prevention and Treatment Center

Status: Completed

Conditions: Myopia

Treatments: Device: LLLT（Low Level Laser Therapy）

Study type: Interventional

Funder types: Other

Identifiers

NCT04825769

SHYB2021001

Details and patient eligibility

About

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.

Enrollment: 278 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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278 participants in 2 patient groups

Intervention

Experimental group

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

Treatment:

Device: LLLT（Low Level Laser Therapy）

Control

No Intervention group

Description:

No intervention