Red Light Intervention on Myopic Progression

Shanghai Eye Disease Prevention and Treatment Center

Status: Enrolling

Conditions: Myopia

Treatments: Drug: Atropine; Device: Red Light Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05203432

21Y11910000

Details and patient eligibility

About

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

Enrollment: 104 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Red Light Intervention

Experimental group

Description:

Repeated Low-Level Red-Light Therapy

Treatment:

Device: Red Light Intervention

Low concentration atropine

Active Comparator group

Description:

0.01% atropine

Treatment:

Drug: Atropine