Red Light Intervention on Myopic Progression
The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
1 other identifier
interventional
104
1 country
1
Brief Summary
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedOctober 12, 2022
January 1, 2022
2.4 years
January 10, 2022
October 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of axial length
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
at least 1 year
Secondary Outcomes (3)
Change of spherical equivalent
at least 1 year
Change of choroidal thickness
at least 1 year
Change of uncorrected visual acuity
at least 1 year
Study Arms (2)
Red Light Intervention
EXPERIMENTALRepeated Low-Level Red-Light Therapy
Low concentration atropine
ACTIVE COMPARATOR0.01% atropine
Interventions
Eligibility Criteria
You may qualify if:
- Age at enrolment: 6-12 years;
- At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
- Anisometropia of 1.5 D or less;
- The BCVA of distant vision is at least 0.8;
- Myopia progressed more than 0.5D in the past year;
- Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- Written informed consent of guardian and child.
You may not qualify if:
- Strabismus, amblyopia or other ocular abnormalities;
- Other systemic abnormalities;
- Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
- Atropine allergy;
- Other situations that not suitable for participating in the trial as judged by the researcher.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, 201103, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiannan Huang
Shanghai Eye Disease Prevention and Treatment Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 24, 2022
Study Start
February 10, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
October 12, 2022
Record last verified: 2022-01