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

NCT06727019 | Completed

• 1 other identifier: BeijingTH2023qiao
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Incidence of myopia

  12-month incidence of myopia

  12 months

Study Arms (2)

red-light

EXPERIMENTAL

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

Device: low-level red-light

atropine

EXPERIMENTAL

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

Drug: Atropine (0.01%)

Interventions

low-level red-light DEVICE

650-nm low-level red-light

red-light

Atropine (0.01%) DRUG

Atropine eye drops at concentration of 0.01%

atropine

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.
• \. 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Liya Qiao, PhD

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 10, 2024
• Study Start: April 10, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)