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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
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It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .
It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. |
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| Study Group 2 | Experimental | With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. |
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| Control Group | Placebo Comparator | Wearing H.A.L.T lens to control myopia only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airdoc Red Lighting Device | Device | A medical device with ultra low lever laser irradiance of 0.6mW or 1.2mW at the surface of cornea. And the therapy lasts 3 minutes with the 4 hours or more interval of break. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm) | Measured with IOLmaster 500 or Lenstar at follow-up from baseline | 3-month |
| Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm) | Measured with IOLmaster 500 or Lenstar at follow-up from baseline | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Refractive Error at follow-up from Baseline (mm) | Measured with autorefractor; Spherical Equivalence is calculated. | 3-month |
| Mean Change of Refractive Error at follow-up from Baseline (mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Wang, MD,PHD | Contact | +8618510386815 | hechao@airdoc.com | |
| Fuyu Zhang, BA | Contact | +8618510386815 | qiukaikai0620@airdoc.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Liu, MD, PHD | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children Medical Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye 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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| Special Spectacles to Control Myopia | Device | Customer designed power and fitting to each subject for all the study periods. |
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Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 * Cyclinder Diopter.
| 6-month |
| Mean Change of Choroidal Thickness (um) | Measured with Optical Coherence Topography (OCT) | 3-month |
| Mean Change of Choroidal Thickness (um) | Measured with Optical Coherence Topography (OCT) | 6-month |
| Change of Fundus | Mesured with color fundus camera with Artificial Intelligence Database | 6-month |