Slow Myopia Progression With Different Irradiance Light
- Conditions
- Myopia, Progressive
- Interventions
- Device: Airdoc Red Lighting DeviceDevice: Special Spectacles to Control Myopia
- Registration Number
- NCT05881655
- Lead Sponsor
- Beijing Airdoc Technology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group 1 Special Spectacles to Control Myopia With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. Control Group Special Spectacles to Control Myopia Wearing H.A.L.T lens to control myopia only. Study Group 2 Special Spectacles to Control Myopia With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. Study Group 1 Airdoc Red Lighting Device With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia. Study Group 2 Airdoc Red Lighting Device With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.
- Primary Outcome Measures
Name Time Method Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm) 6-month Measured with IOLmaster 500 or Lenstar at follow-up from baseline
- Secondary Outcome Measures
Name Time Method Change of Fundus 6-month Mesured with color fundus camera with Artificial Intelligence Database
Mean Change of Choroidal Thickness (um) 6-month Measured with Optical Coherence Topography (OCT)
Mean Change of Refractive Error at follow-up from Baseline (mm) 6-month Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 \* Cyclinder Diopter.
Trial Locations
- Locations (1)
Shanghai Children Medical Center
🇨🇳Shanghai, China