NCT05203432
Unknown
Not Applicable
The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country104 target enrollmentFebruary 10, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Red Light Intervention
- Conditions
- Myopia
- Sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Changes of axial length
- Last Updated
- 3 years ago
Overview
Brief Summary
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age at enrolment: 6-12 years;
- •At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
- •Anisometropia of 1.5 D or less;
- •The BCVA of distant vision is at least 0.8;
- •Myopia progressed more than 0.5D in the past year;
- •Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- •Written informed consent of guardian and child.
Exclusion Criteria
- •Strabismus, amblyopia or other ocular abnormalities;
- •Other systemic abnormalities;
- •Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
- •Atropine allergy;
- •Other situations that not suitable for participating in the trial as judged by the researcher.
Arms & Interventions
Red Light Intervention
Repeated Low-Level Red-Light Therapy
Intervention: Red Light Intervention
Low concentration atropine
0.01% atropine
Intervention: Atropine
Outcomes
Primary Outcomes
Changes of axial length
Time Frame: at least 1 year
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
Secondary Outcomes
- Change of choroidal thickness(at least 1 year)
- Change of spherical equivalent(at least 1 year)
- Change of uncorrected visual acuity(at least 1 year)
Study Sites (1)
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