Back to results650nm Low-level Red-light for Myopia Control and Prevention in Children
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
650 nm low-level red-light
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria: Children aged 6 to 12 years The cycloplegic spherical equivalent error (SER) is -6D to 1D (> -6D, ≤1D) in both eyes Astigmatism of 2.5 D or less (≤2.5D) Willing to participate in the study and sign the informed consent form Exclusion Criteria: Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia With refractive media opacification (keratopathy, lens opacity, etc.) Allergy to cycloplegia drugs
Sites / Locations
- Beijing Tongren HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
650 nm low-level red-light, plus single vision spectacle lenses
Control
Arm Description
Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children.
Single vision spectacle lenses are allowed for myopic children. No intervention was given.
Outcomes
Primary Outcome Measures
Change in axial length
Use an optical biometer to measure the axial length.
Change in spherical equivalent error
Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
Secondary Outcome Measures
Change in Choroid thickness
Use an enhanced-depth imaging technique (based on Optical coherence tomography )
Change in steep keratometry
Use an optical biometer
Change in flat keratometry
Use an optical biometer
Change in length thickness
Use an optical biometer
Change in anterior chamber depth
Use an optical biometer
Change in central corneal thickness
Use an optical biometer
Full Information
NCT ID
NCT05786586
First Posted
January 29, 2023
Last Updated
April 7, 2023
Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics
1. Study Identification
Unique Protocol Identification Number
NCT05786586
Brief Title
650nm Low-level Red-light for Myopia Control and Prevention in Children
Official Title
Repeated Exposure to 650nm Low-level Red-light for Myopia Control and Prevention in Children: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicenter randomized controlled trial, evaluating the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children. Participants included children(aged 6 to 12 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
Detailed Description
This multicenter randomized controlled trial will be conducted in three hospitals: Beijing Tongren Hospital, and another two subcenters. The whole study will last for five years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up and the end of the study. The intervention measure used will be 650 nm low-level red-light. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
572 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
650 nm low-level red-light, plus single vision spectacle lenses
Arm Type
Experimental
Arm Description
Children in the treatment group are expected to receive 6 minutes irradiation of 650 nm low-level red-light daily, divided into two times a day, each lasting for 3 minutes. Single vision spectacle lenses are allowed for myopic children.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Single vision spectacle lenses are allowed for myopic children. No intervention was given.
Intervention Type
Device
Intervention Name(s)
650 nm low-level red-light
Intervention Description
650 nm low-level red-light is a kind of laser, concentrated into a beam, to repeatedly irradiate the retina
Primary Outcome Measure Information:
Title
Change in axial length
Description
Use an optical biometer to measure the axial length.
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in spherical equivalent error
Description
Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Secondary Outcome Measure Information:
Title
Change in Choroid thickness
Description
Use an enhanced-depth imaging technique (based on Optical coherence tomography )
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in steep keratometry
Description
Use an optical biometer
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in flat keratometry
Description
Use an optical biometer
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in length thickness
Description
Use an optical biometer
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in anterior chamber depth
Description
Use an optical biometer
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Title
Change in central corneal thickness
Description
Use an optical biometer
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
Other Pre-specified Outcome Measures:
Title
Fundus injury related to 650 nm low-level red-light irridiation
Description
Any potential fundus injury related to 650 nm low-level red-light irridiation would be checked through Fundus photography and coherence tomography examination
Time Frame
Baseline, six-month follow-up, one-year follow-up, two-year follow-up, three-year follow-up, four-year follow-up, five-year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6 to 12 years
The cycloplegic spherical equivalent error (SER) is -6D to 1D (> -6D, ≤1D) in both eyes
Astigmatism of 2.5 D or less (≤2.5D)
Willing to participate in the study and sign the informed consent form
Exclusion Criteria:
Using other myopia interventions or stopped using them for less than three months, including but not limited to atropine eye drops or orthokeratology lens
With anisometropia (difference in sphere between two eyes was 1.5D or greater), strabismus, or amblyopia
With refractive media opacification (keratopathy, lens opacity, etc.)
Allergy to cycloplegia drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Cao
Phone
01058265900
Email
caozhi@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Jie
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Cao
Phone
01058265900
Email
caozhi@ccmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
650nm Low-level Red-light for Myopia Control and Prevention in Children
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