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Slow Myopia Progression With Different Irradiance Light

Primary Purpose

Myopia, Progressive

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Airdoc Red Lighting Device
Special Spectacles to Control Myopia
Sponsored by
Beijing Airdoc Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Children Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Study Group 1

Study Group 2

Control Group

Arm Description

With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens 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.

Wearing H.A.L.T lens to control myopia only.

Outcomes

Primary Outcome Measures

Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Measured with IOLmaster 500 or Lenstar at follow-up from baseline

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2023
Last Updated
May 21, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
Shanghai Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05881655
Brief Title
Slow Myopia Progression With Different Irradiance Light
Official Title
A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
Shanghai Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
With 1.2mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
With 0.6mW lighting power of red light at wavelenth of 650nm and wearing H.A.L.T lens to control myopia.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Wearing H.A.L.T lens to control myopia only.
Intervention Type
Device
Intervention Name(s)
Airdoc Red Lighting Device
Other Intervention Name(s)
Repeated Red Light, Low Lever Laser Therapy, Low Intensity Light Therapy, Photobiomodulation Therapy, Seconee, 650nm Red Light
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Special Spectacles to Control Myopia
Other Intervention Name(s)
Essilor® Stellest™ Lenses, H.A.L.T lens
Intervention Description
Customer designed power and fitting to each subject for all the study periods.
Primary Outcome Measure Information:
Title
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Description
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Time Frame
3-month
Title
Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
Description
Measured with IOLmaster 500 or Lenstar at follow-up from baseline
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Mean Change of Refractive Error at follow-up from Baseline (mm)
Description
Measured with autorefractor; Spherical Equivalence is calculated.
Time Frame
3-month
Title
Mean Change of Refractive Error at follow-up from Baseline (mm)
Description
Measured with autorefractor; Spherical Equivalence is calculated according to the formular of SE=Spherical +1/2 * Cyclinder Diopter.
Time Frame
6-month
Title
Mean Change of Choroidal Thickness (um)
Description
Measured with Optical Coherence Topography (OCT)
Time Frame
3-month
Title
Mean Change of Choroidal Thickness (um)
Description
Measured with Optical Coherence Topography (OCT)
Time Frame
6-month
Title
Change of Fundus
Description
Mesured with color fundus camera with Artificial Intelligence Database
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Wang, MD,PHD
Phone
+8618510386815
Email
hechao@airdoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuyu Zhang, BA
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD, PHD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Children Medical Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanghai Children Medical Center Zhang, MD
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Slow Myopia Progression With Different Irradiance Light

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