Back to resultsReal Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old (RMC)
Primary Purpose
Myopia, Amblyopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
repeated ultra low lever red light
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia, Children, LLLT, PBM
Eligibility Criteria
Inclusion Criteria: 3~6 years old; Myopia Spherical Equivalence Refraction <=-0.50D; Written Informed Consent; Exclusion Criteria: Cannot approval with written informed consent; Photophobia or allergy to red light; With other severe conditions the principle investigators refused to enroll this study
Sites / Locations
- Guangzhou Women and Children's Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
repeated red light therapy for 3~4 year-old myopia
repeated red light therapy for 5~6 year-old myopia
Arm Description
0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia.
0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia.
Outcomes
Primary Outcome Measures
Mean changes of axial length vaules by millimeter at follow-up from baseline.
Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.
Secondary Outcome Measures
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)
Cycloplegic refraction changes from baseline will be measured and recorded at follow-up and at baseline. Spherical equivalence will be calculated with the formular of SE=spherical diopter+1/2cylinder diopter
Number of Participants with unsafety issues during the study
Adverse event and device failure rate
Full Information
NCT ID
NCT05811598
First Posted
March 31, 2023
Last Updated
April 22, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05811598
Brief Title
Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
Acronym
RMC
Official Title
Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
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
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.
Detailed Description
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (3~4 years old and 5~6 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Amblyopia
Keywords
Myopia, Children, LLLT, PBM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups for the 2 lighting lever (0.37mW and 0.6mW）for 2 groups of ages (3~4 years old and 5~6 years old)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
repeated red light therapy for 3~4 year-old myopia
Arm Type
Experimental
Arm Description
0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia.
Arm Title
repeated red light therapy for 5~6 year-old myopia
Arm Type
Experimental
Arm Description
0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia.
Intervention Type
Device
Intervention Name(s)
repeated ultra low lever red light
Other Intervention Name(s)
LLLT, PBM therapy
Intervention Description
Myopia indoor lighting therapy
Primary Outcome Measure Information:
Title
Mean changes of axial length vaules by millimeter at follow-up from baseline.
Description
Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.
Time Frame
at 3-month and at 6-month
Secondary Outcome Measure Information:
Title
Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)
Description
Cycloplegic refraction changes from baseline will be measured and recorded at follow-up and at baseline. Spherical equivalence will be calculated with the formular of SE=spherical diopter+1/2cylinder diopter
Time Frame
at 3-month and at 6-month
Title
Number of Participants with unsafety issues during the study
Description
Adverse event and device failure rate
Time Frame
at 6-month
Other Pre-specified Outcome Measures:
Title
Rate of subjects meet with repeated red light thearpy greater than 85% of the specified requirementsfrequence record
Description
Twice daily with an interval of 4 hours or mor, and 3 minutes at each session
Time Frame
at 1-month, 3-month and 6-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3~6 years old;
Myopia Spherical Equivalence Refraction <=-0.50D;
Written Informed Consent;
Exclusion Criteria:
Cannot approval with written informed consent;
Photophobia or allergy to red light;
With other severe conditions the principle investigators refused to enroll this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wensi Shen, MD,PhD
Phone
+8613631318044
Email
369353779@QQ.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Qiu, MD
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao He, PhD
Organizational Affiliation
Beijing Airdoc Technology Co., Ltd.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daoman Xiang, MD, PhD
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wensi Shen, MD, PhD
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wensi Shen, MD. & Ph.D.
Phone
+8613631318044
Email
369353779@qq.com
First Name & Middle Initial & Last Name & Degree
Daoman Xiang, MD & PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
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