Back to resultsRed Light Intervention on Myopic Progression
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Red Light Intervention
Atropine
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Eye Disease Prevention and Treatment CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Red Light Intervention
Low concentration atropine
Arm Description
Repeated Low-Level Red-Light Therapy
0.01% atropine
Outcomes
Primary Outcome Measures
Changes of axial length
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
Secondary Outcome Measures
Change of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Change of choroidal thickness
Choroidal thickness will be measured using SS-OCT
Change of uncorrected visual acuity
Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.
Full Information
NCT ID
NCT05203432
First Posted
January 10, 2022
Last Updated
October 7, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT05203432
Brief Title
Red Light Intervention on Myopic Progression
Official Title
The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
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
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Red Light Intervention
Arm Type
Experimental
Arm Description
Repeated Low-Level Red-Light Therapy
Arm Title
Low concentration atropine
Arm Type
Active Comparator
Arm Description
0.01% atropine
Intervention Type
Device
Intervention Name(s)
Red Light Intervention
Intervention Description
Repeated Low-Level Red-Light Therapy
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
0.01% atropine
Primary Outcome Measure Information:
Title
Changes of axial length
Description
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
Time Frame
at least 1 year
Secondary Outcome Measure Information:
Title
Change of spherical equivalent
Description
Spherical equivalent as measured by cycloplegia autorefraction
Time Frame
at least 1 year
Title
Change of choroidal thickness
Description
Choroidal thickness will be measured using SS-OCT
Time Frame
at least 1 year
Title
Change of uncorrected visual acuity
Description
Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.
Time Frame
at least 1 year
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:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiannan Huang
Phone
+8602153555032
Email
miller23@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangui He
Phone
+8602153555032
Email
hxgcrco@shsyf.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiannan Huang
Organizational Affiliation
Shanghai Eye Disease Prevention and Treatment Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
ZIP/Postal Code
201103
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangui He
Phone
+862153555032
Email
hxgcrco@shsyf.com
12. IPD Sharing Statement
Learn more about this trial
Red Light Intervention on Myopic Progression
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