NCT05881655

Slow Myopia Progression With Different Irradiance Light

A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Beijing Airdoc Technology Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	Airdoc 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.
DEVICE	Special Spectacles to Control Myopia	Customer designed power and fitting to each subject for all the study periods.

Timeline

• Start date: 2023-05-20
• Primary completion: 2024-05-30
• Completion: 2025-12-30
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: China