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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repeated red light therapy for 3~4 year-old myopia | Experimental | 0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia. |
|
| repeated red light therapy for 5~6 year-old myopia | Experimental | 0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repeated ultra low lever red light | Device | Myopia indoor lighting therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 3-month and at 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 3-month and at 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects meet with repeated red light thearpy greater than 85% of the specified requirementsfrequence record | Twice daily with an interval of 4 hours or mor, and 3 minutes at each session | at 1-month, 3-month and 6-month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wensi Shen, MD,PhD | Contact | +8613631318044 | 369353779@QQ.COM | |
| Jenny Qiu, MD | Contact | +8618510386815 | qiukaikai0620@airdoc.com |
| Name | Affiliation | Role |
|---|---|---|
| Chao He, PhD | Beijing Airdoc Technology Co., Ltd. | Study Director |
| Daoman Xiang, MD, PhD | Guangzhou Women and Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Women and Children's Medical Center | Recruiting | Guangzhou | Guangdong | 510600 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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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)
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|
| Number of Participants with unsafety issues during the study | Adverse event and device failure rate | at 6-month |
| Wensi Shen, MD, PhD |
| Guangzhou Women and Children's Medical Center |
| Study Chair |
| D009422 |
| Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |