Red Light Intervention on Myopic Progression

Not Applicable

• Conditions: Myopia
• Interventions: Device: Red Light Intervention; Drug: Atropine

• Registration Number: NCT05203432
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-02-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Age at enrolment: 6-12 years;
2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
3. Anisometropia of 1.5 D or less;
4. The BCVA of distant vision is at least 0.8;
5. Myopia progressed more than 0.5D in the past year;
6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
7. Written informed consent of guardian and child.

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Exclusion Criteria

1. Strabismus, amblyopia or other ocular abnormalities;
2. Other systemic abnormalities;
3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
4. Atropine allergy;
5. Other situations that not suitable for participating in the trial as judged by the researcher.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red Light Intervention	Red Light Intervention	Repeated Low-Level Red-Light Therapy
Low concentration atropine	Atropine	0.01% atropine

Primary Outcome Measures

Name	Time	Method
Changes of axial length	at least 1 year	AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster

Secondary Outcome Measures

Name	Time	Method
Change of choroidal thickness	at least 1 year	Choroidal thickness will be measured using SS-OCT
Change of spherical equivalent	at least 1 year	Spherical equivalent as measured by cycloplegia autorefraction
Change of uncorrected visual acuity	at least 1 year	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)

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, China