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OpenTrials
Completed

NCT Number: NCT06727019

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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.
  • 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.

Treatment and study plan

low-level red-light

Device

650-nm low-level red-light

Atropine (0.01%)

Drug

Atropine eye drops at concentration of 0.01%

Primary outcomes

  1. Incidence of myopia

    Time frame: 12 months

    12-month incidence of myopia

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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