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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: low-level red-light; Drug: Atropine (0.01%)

• Registration Number: NCT06727019
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-10
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
red-light	low-level red-light	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
atropine	Atropine (0.01%)	participants in the atropine group used 0.01% low-dose atropine eye drops once each night

Primary Outcome Measures

Name	Time	Method
Incidence of myopia	12 months	12-month incidence of myopia

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China