Red Light Intervention on Myopic Progression

NCT ID: NCT05203432

Last Updated: 2022-10-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2024-06-30

Brief Summary

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To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Red Light Intervention

Repeated Low-Level Red-Light Therapy

Group Type EXPERIMENTAL

Red Light Intervention

Intervention Type DEVICE

Repeated Low-Level Red-Light Therapy

Low concentration atropine

0.01% atropine

Group Type ACTIVE_COMPARATOR

Atropine

Intervention Type DRUG

0.01% atropine

Interventions

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Red Light Intervention

Repeated Low-Level Red-Light Therapy

Intervention Type DEVICE

Atropine

0.01% atropine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age at enrolment: 6-12 years;
2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
3. Anisometropia of 1.5 D or less;
4. The BCVA of distant vision is at least 0.8;
5. Myopia progressed more than 0.5D in the past year;
6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
7. Written informed consent of guardian and child.

Exclusion Criteria

1. Strabismus, amblyopia or other ocular abnormalities;
2. Other systemic abnormalities;
3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
4. Atropine allergy;
5. Other situations that not suitable for participating in the trial as judged by the researcher.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiannan Huang

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Disease Prevention and Treatment Center

Locations

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Shanghai Eye Disease Prevention and Treatment Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiannan Huang

Role: CONTACT

+8602153555032

Xiangui He

Role: CONTACT

+8602153555032

Facility Contacts

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Xiangui He

Role: primary

+862153555032

Other Identifiers

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21Y11910000

Identifier Type: -

Identifier Source: org_study_id

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