Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Beijing Airdoc Technology Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Mean changes of axial length vaules by millimeter at follow-up from baseline.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Mean changes of axial length vaules by millimeter at follow-up from baseline.
Time Frame: 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 Outcomes
- 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)
- Number of Participants with unsafety issues during the study(at 6-month)