Red Light Intervention for Myopia Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

LLLT（Low Level Laser Therapy）

Intervention Type 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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No