Myopia, Progressive
Conditions
Brief summary
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 .
Detailed description
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.
Interventions
DEVICEAirdoc Red Lighting 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.
DEVICESpecial Spectacles to Control Myopia
Customer designed power and fitting to each subject for all the study periods.
Sponsors
Shanghai Children's Medical Center
Beijing Airdoc Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 6\ 12 years old * Refractive Error of Myopia within -0.50 D\ -5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record). * Written consent formed with supervisions and children with 6 month follow-up.
Exclusion criteria
* Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate). * Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus. * Strabisumus with angles large or equal to 5 prism dioper. * With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm) | 3-month | Measured with IOLmaster 500 or Lenstar at follow-up from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Refractive Error at follow-up from Baseline (mm) | 3-month | Measured with autorefractor; Spherical Equivalence is calculated. |
| Mean Change of Choroidal Thickness (um) | 3-month | Measured with Optical Coherence Topography (OCT) |
| Change of Fundus | 6-month | Mesured with color fundus camera with Artificial Intelligence Database |
Countries
China
Contacts
Primary ContactSophia Wang, MD,PHD
Backup ContactFuyu Zhang, BA
Outcome results
None listed