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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Shanghai Children Medical Center
RECRUITING
Shanghai
Contact Information
Primary
Sophia Wang, MD,PHD
hechao@airdoc.com
+8618510386815
Backup
Fuyu Zhang, BA
qiukaikai0620@airdoc.com
+8618510386815
Time Frame
Start Date: 2023-05-20
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 75
Treatments
Experimental: Study Group 1
With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.
Experimental: Study Group 2
With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.
Placebo_comparator: Control Group
Wearing H.A.L.T lens to control myopia only.
Related Therapeutic Areas
Sponsors
Leads: Beijing Airdoc Technology Co., Ltd.
Collaborators: Shanghai Children's Medical Center

This content was sourced from clinicaltrials.gov