Red Light Intervention for Myopia Prevention

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: LLLT（Low Level Laser Therapy）

• Registration Number: NCT04825769
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study Start: 2021-03-25
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	LLLT（Low Level Laser Therapy）	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
The progress of axial length of children in intervention group and control group.	1 year	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.	1 year	The choroidal thickness will be measured using SS-OCT.
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.

Trial Locations

Locations (1)

Xiangui He; 🇨🇳 Shanghai, Shanghai, China