Amblyopia, Myopia
Conditions
Keywords
Myopia, Children, LLLT, PBM
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.
Interventions
DEVICErepeated ultra low lever red light
Myopia indoor lighting therapy
Sponsors
Beijing Airdoc Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean changes of axial length vaules by millimeter at follow-up from baseline. | at 3-month and at 6-month | 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
| Measure | Time frame | Description |
|---|---|---|
| Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D) | at 3-month and at 6-month | 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 | at 6-month | Adverse event and device failure rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects meet with repeated red light thearpy greater than 85% of the specified requirementsfrequence record | at 1-month, 3-month and 6-month | Twice daily with an interval of 4 hours or mor, and 3 minutes at each session |
Countries
China
Contacts
Primary ContactWensi Shen, MD,PhD
Backup ContactJenny Qiu, MD
Outcome results
None listed