Daily Low-level Red Light and 0.01% Low-dose Atropine for Myopia Prevention

Capital Medical University

Status: Completed

Conditions: Myopia

Treatments: Drug: Atropine (0.01%); Device: low-level red-light

Study type: Interventional

Funder types: Other

Identifiers

NCT06727019

BeijingTH2023qiao

Details and patient eligibility

About

To compare the preventive effects of daily low-level red-light and 0.01% low-dose atropine eye drops on myopia.

Enrollment: 138 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Aged at least 7 years old. 2. The spherical equivalent error (SER) after pupil dilation was between -0.5 D and +0.75D.

  2. Had a record of cycloplegia SER at least 6 months before this study, and SER changed -0.5D compared with the last measurement or had a family history of high myopia.

  3. Corneal astigmatism ≤ 1.25D. 5. Interocular refraction discrepancy ≤ 1.5D. 6. No allergy history of cycloplegia drugs. 7. Willingness to participate in the study and signed informed consent.

Exclusion criteria

• 1. Intraocular pressure was below 10 mm Hg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.

3. Children currently using other myopia interventions other than LDA or LLRL. 4. Children with systemic and immune disorders, such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, and diabetes 5. Individuals with conditions like Tourette's syndrome or epilepsy.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

red-light

Experimental group

Description:

In the low-level red-light (LLRL) group, the children used LLRL irradiation twice a day for 3-minute sessions, ensuring a gap of over 4 h between each use

Treatment:

Device: low-level red-light

atropine

Experimental group

Description:

participants in the atropine group used 0.01% low-dose atropine eye drops once each night

Treatment:

Drug: Atropine (0.01%)