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

NCT ID: NCT06727019

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2023-09-15

Brief Summary

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

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

low-level red-light

Intervention Type DEVICE

650-nm low-level red-light

atropine

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

Group Type EXPERIMENTAL

Atropine (0.01%)

Intervention Type DRUG

Atropine eye drops at concentration of 0.01%

Interventions

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low-level red-light

650-nm low-level red-light

Intervention Type DEVICE

Atropine (0.01%)

Atropine eye drops at concentration of 0.01%

Intervention Type DRUG

Eligibility Criteria

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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.

3\. 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.

4\. 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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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cao kai

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liya Qiao, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

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Beijing Tongren Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BeijingTH2023qiao

Identifier Type: -

Identifier Source: org_study_id