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

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 .

Study Overview

• Status: Recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: Airdoc Red Lighting Device; Device: Special Spectacles to Control Myopia

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Wang, MD,PHD; Phone Number: +8618510386815; Email: hechao@airdoc.com
• Study Contact Backup: Name: Fuyu Zhang, BA; Phone Number: +8618510386815; Email: qiukaikai0620@airdoc.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Children Medical Center
    • Contact: Shanghai Children Medical Center Zhang, MD; Phone Number: +8618510386815; Email: qiukaikai0620@airdoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light; Device: Special Spectacles to Control Myopia; Customer designed power and fitting to each subject for all the study periods.; Other Names: Essilor® Stellest™ Lenses; H.A.L.T lens
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.	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.; Other Names: Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light; Device: Special Spectacles to Control Myopia; Customer designed power and fitting to each subject for all the study periods.; Other Names: Essilor® Stellest™ Lenses; H.A.L.T lens
Placebo Comparator: Control Group; Wearing H.A.L.T lens to control myopia only.	Device: Special Spectacles to Control Myopia; Customer designed power and fitting to each subject for all the study periods.; Other Names: Essilor® Stellest™ Lenses; H.A.L.T lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change of Refractive Error at follow-up from Baseline (mm)	Measured with autorefractor; Spherical Equivalence is calculated.	3-month
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
Mean Change of Choroidal Thickness (um)	Measured with Optical Coherence Topography (OCT)	3-month
Mean Change of Choroidal Thickness (um)	Measured with Optical Coherence Topography (OCT)	6-month
Change of Fundus	Mesured with color fundus camera with Artificial Intelligence Database	6-month

Collaborators and Investigators

• Sponsor: Beijing Airdoc Technology Co., Ltd.
• Collaborators: Shanghai Children's Medical Center
• Investigators: Principal Investigator: Hong Liu, MD, PHD, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: Airdoc MPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No