Back to resultsClinical Study of Light Therapy to Control Myopia Progression in Children
Primary Purpose
Myopia, Progressive
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Photobiomodualtion Therapy
Single vision spectacles for correction myopia
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive
Eligibility Criteria
Inclusion Criteria: Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited; Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D); Best corrected vision in one eye under glasses correction: 0.1 log MAR; No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests; No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight); Exclusion Criteria: Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia; Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc. Subject participated in other clinical trials within 4 weeks before the enrollment; The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
Sites / Locations
- Eye & ENT hospital of Fudan universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PBM therapy 1
PBM therapy 2
Control
Arm Description
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.
Single vision spectacles correction only.
Outcomes
Primary Outcome Measures
Changes in axial length (mm）
Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500
Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline
Secondary Outcome Measures
Changes in cycloplegic autorefraction (diopters, D)
Objective refraction measured by using Autorefractor. Five measurements are obtained for each eye and the average of spherical equivalence was used for statistical analysis. The measurements will be both with cycloplegia at baseline and at follow-up. The changes in cycloplegic autorefraction are calculated in the mean value of each group.
Changes of choroidal thickness under macular foveal (um)
Swept-source optical coherence tomography (OCT) and OCT angiography were used To measure choroidal fovea thickness at baseline and at follow-up. To avoid the effects of circadian rhythm on the results, OCT scanning was performed twice by the same investigator between 8:00 A.M. and 2:00 P.M. at baseline and 1-month follow-up. Two independent skilled professionals measured the sub-foveal choroidal thickness （SFChT) using a linear measurement program during the OCT scan. To increase the visibility of the choroid, the enhanced depth imaging mode was used. We defined the thinnest part of the macula in the image as the fovea. The SFChT was measured from the outermost part of the retinal pigment epithelium to the inner layer of the the choroidoscleral interface.
Changes of cornea power
Changes in the central anterior cornea power by the value measured from auto-refraction. The mean values will be recorded as well as the mean values at follow-up of 1 month
Change in retina fovea perfusion density (RFPD, %)
Swept-source optical coherence tomography (OCT) angiography is used to measure retina fovea perfusion density (RFPD). The TowardPi OCTA allow for the in vivo visualization of three-dimensional (3-D) vascular networks in the retina and choroid. The OCTA images were acquired by the TowardPi-3D spatial identification algorithm. The retina vessels and choriocapillaris were identified by higher order moments decorrelation algorithm. The medium- and large-sized choroid vessels from Sattler's layer and Haller's layer were visualized by 3D threshold segmentation algorithm. In this study, the retinal and choroidal images were obtained with an area of 18*18 mm centered on the fovea. In addition, for a comprehensive analysis of the macular zone, we adopted the Early Treatment Diabetic Retinopathy Study (ETDRS) grid using the instrument's software which was adjusted for each individual participant's ocular magnification.
Full Information
NCT ID
NCT05761379
First Posted
February 3, 2023
Last Updated
July 31, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05761379
Brief Title
Clinical Study of Light Therapy to Control Myopia Progression in Children
Official Title
Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.
Detailed Description
LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.
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
Model Description
Low lever red light therapy with Model : Sky-n1201c at the wavelength of 650nm; 3 minutes illumination for both eyes, administered twice daily at the interview of 4 hours.
Children in the red light therapy group wore single vision spectacles the entire day and under red light therapy (power, 0.6mW; wavelength, 650nm; Beijing Airdoc MPC Co. Ltd, Beijing, China) twice per day for 3 minutes each session, with at least a 4-hour interval between sessions. There were no specific guidelines for room illumination. After the first measurement session, each child returned for follow-up examinations at 1, 3, and 6 months and completed all the aforementioned examinations.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PBM therapy 1
Arm Type
Experimental
Arm Description
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.6±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. The lighting spot for therapy is a dot. Only one eye will be treated with PBM therapy.
Arm Title
PBM therapy 2
Arm Type
Experimental
Arm Description
PBM therapy was performed with a low-intensity laser (Airdoc, MPC Co.,Ltd., Beijing, China) with an irradiance of 0.3±0.2 mW, a wavelength of 650 nm±10 nm, and illumination of approximately 400 lux on average. Only one eye will be treated with PBM therapy.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Single vision spectacles correction only.
Intervention Type
Device
Intervention Name(s)
Photobiomodualtion Therapy
Other Intervention Name(s)
Myopia light therapy; Low lever light therapy; Low lever laser therapy; Low intensity red light thearpy
Intervention Description
low lever light therapy with laser semi-conductor at wavelength of 650nm
Intervention Type
Device
Intervention Name(s)
Single vision spectacles for correction myopia
Other Intervention Name(s)
Glasseses
Intervention Description
Provide the distance best corrected vision acuity of refractive error of myopia for all the groups
Primary Outcome Measure Information:
Title
Changes in axial length (mm）
Description
Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500
Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline
Time Frame
at 1-month Follow-up
Secondary Outcome Measure Information:
Title
Changes in cycloplegic autorefraction (diopters, D)
Description
Objective refraction measured by using Autorefractor. Five measurements are obtained for each eye and the average of spherical equivalence was used for statistical analysis. The measurements will be both with cycloplegia at baseline and at follow-up. The changes in cycloplegic autorefraction are calculated in the mean value of each group.
Time Frame
at 1-month Follow-up and at baseline
Title
Changes of choroidal thickness under macular foveal (um)
Description
Swept-source optical coherence tomography (OCT) and OCT angiography were used To measure choroidal fovea thickness at baseline and at follow-up. To avoid the effects of circadian rhythm on the results, OCT scanning was performed twice by the same investigator between 8:00 A.M. and 2:00 P.M. at baseline and 1-month follow-up. Two independent skilled professionals measured the sub-foveal choroidal thickness （SFChT) using a linear measurement program during the OCT scan. To increase the visibility of the choroid, the enhanced depth imaging mode was used. We defined the thinnest part of the macula in the image as the fovea. The SFChT was measured from the outermost part of the retinal pigment epithelium to the inner layer of the the choroidoscleral interface.
Time Frame
at 1-month Follow-up and at baseline
Title
Changes of cornea power
Description
Changes in the central anterior cornea power by the value measured from auto-refraction. The mean values will be recorded as well as the mean values at follow-up of 1 month
Time Frame
at 1-month Follow-up and at baseline
Title
Change in retina fovea perfusion density (RFPD, %)
Description
Swept-source optical coherence tomography (OCT) angiography is used to measure retina fovea perfusion density (RFPD). The TowardPi OCTA allow for the in vivo visualization of three-dimensional (3-D) vascular networks in the retina and choroid. The OCTA images were acquired by the TowardPi-3D spatial identification algorithm. The retina vessels and choriocapillaris were identified by higher order moments decorrelation algorithm. The medium- and large-sized choroid vessels from Sattler's layer and Haller's layer were visualized by 3D threshold segmentation algorithm. In this study, the retinal and choroidal images were obtained with an area of 18*18 mm centered on the fovea. In addition, for a comprehensive analysis of the macular zone, we adopted the Early Treatment Diabetic Retinopathy Study (ETDRS) grid using the instrument's software which was adjusted for each individual participant's ocular magnification.
Time Frame
at 1-month Follow-up and at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
Best corrected vision in one eye under glasses correction: 0.1 log MAR;
No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);
Exclusion Criteria:
Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
Subject participated in other clinical trials within 4 weeks before the enrollment;
The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Qiu, M.D.
Phone
+8618510386815
Email
qiukaikai0620@airdoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chao He, Ph.D.
Email
hechao@airdoc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingtao Zhou, M.D. PhD.
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weicun Chen, MD, PhD
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Meiyan Li, MD, PhD
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Eye & ENT hospital of Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyan Li, MD.Ph.D.
First Name & Middle Initial & Last Name & Degree
Weiming Yang, MD. PhD
First Name & Middle Initial & Last Name & Degree
Xiaoying Wang, MD. PhD.
First Name & Middle Initial & Last Name & Degree
Xingtao Zhou, MD. PhD
First Name & Middle Initial & Last Name & Degree
Weicun Chen, MD. PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36315988
Citation
Yang W, Lin F, Li M, Wei R, Zhou J, Zhou X. Immediate effect in retina and choroid after 650 nm low-level red light therapy in children. Ophthalmic Res. 2022 Oct 31. doi: 10.1159/000527787. Online ahead of print.
Results Reference
background
PubMed Identifier
36556114
Citation
Liu G, Li B, Rong H, Du B, Wang B, Hu J, Zhang B, Wei R. Axial Length Shortening and Choroid Thickening in Myopic Adults Treated with Repeated Low-Level Red Light. J Clin Med. 2022 Dec 17;11(24):7498. doi: 10.3390/jcm11247498.
Results Reference
background
Learn more about this trial
Clinical Study of Light Therapy to Control Myopia Progression in Children
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