Slow Myopia Progression With Different Irradiance Light

Myopia, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881655
• Other study ID #: Airdoc MPC
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: Sophia Wang, MD,PHD
• Phone: +8618510386815
• Email: hechao[@]airdoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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.
• Special Spectacles to Control Myopia
Customer designed power and fitting to each subject for all the study periods.

Locations

Country	Name	City	State
China	Shanghai Children Medical Center	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.	Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Mean Change of Refractive Error at follow-up from Baseline (mm)	Measured with autorefractor; Spherical Equivalence is calculated.	3-month
Secondary	Mean Change of Refractive Error at follow-up from Baseline (mm)	Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 * Cyclinder Diopter.	6-month
Secondary	Mean Change of Choroidal Thickness (um)	Measured with Optical Coherence Topography (OCT)	3-month
Secondary	Mean Change of Choroidal Thickness (um)	Measured with Optical Coherence Topography (OCT)	6-month
Secondary	Change of Fundus	Mesured with color fundus camera with Artificial Intelligence Database	6-month