Back to resultsRepeated Low-Level Red-Light Therapy for Shortening Axial Length
Primary Purpose
High Myopia, Refractive Errors, Eye Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RLRL
Sponsored by
About this trial
This is an interventional treatment trial for High Myopia
Eligibility Criteria
Inclusion Criteria:
- Provision of consent.
- Age: ≥ 6 and ≤ 16 years at enrolment.
- High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
- Willing and able to participate in all required activities of the study.
- The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
- Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
Exclusion Criteria:
- Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- Strabismus and binocular vision abnormalities in either eye.
- Previous any intraocular surgery affecting refractive status.
- Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Sites / Locations
- Shanghai Eye Disease Prevention and Treatment Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RLRL therapy
Arm Description
In addition to SVS, participants will be treated with RLRL twice a school day.
Outcomes
Primary Outcome Measures
Incidence rate of axial length shortening >0.05 mm
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number. The IOL Master is used to measure axial length (mm).
Secondary Outcome Measures
Incidence rates of axial length shortening >0.10 mm and >0.20 mm
Incidence rate of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of number of participants with axial length hortening greater than 0.10 mm and 0.20 mm to the total number. The IOL Master is used to measure axial length (mm).
Magnitude of axial length shortening among shortened eyes
Magnitude of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes. The IOL Master is used to measure axial length (mm).
Changes in choroidal structural and perfusion parameters
Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Swept-source optical coherence tomography and optical coherence tomography angiography are used to measure choroidal structural and perfusion parameters.
Changes in retinal structures
Swept-source optical coherence tomography is used to measure retinal structures.
Changes in axial length and other biometric parameters
The IOL Master is used to measure axial length and other biometric parameters, including corneal curvature, anterior chamber depth and white to white, etc. Change of each parameter is characterized as the difference between each follow-up visit and baseline values
Change of cycloplegic spherical equivalent refraction (Diopter)
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D)
Change of pathologic myopia fundus META-PM grading
The swept-source optical coherence tomography is used to obtain fundus images. The fundus images are classified based on META-PM classification system
Change in best corrected visual acuity
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. An Early Treatment Diabetic Retinopathy Study chart with standard illumination at a distance of 4 meters is used to measure best corrected visual acuity
Incidence of self-reported adverse events
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages
Full Information
NCT ID
NCT05550740
First Posted
September 20, 2022
Last Updated
October 17, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT05550740
Brief Title
Repeated Low-Level Red-Light Therapy for Shortening Axial Length
Official Title
Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 22, 2022 (Anticipated)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment 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
The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.
Detailed Description
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Myopia, Refractive Errors, Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RLRL therapy
Arm Type
Experimental
Arm Description
In addition to SVS, participants will be treated with RLRL twice a school day.
Intervention Type
Device
Intervention Name(s)
RLRL
Intervention Description
In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.
Primary Outcome Measure Information:
Title
Incidence rate of axial length shortening >0.05 mm
Description
Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number. The IOL Master is used to measure axial length (mm).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence rates of axial length shortening >0.10 mm and >0.20 mm
Description
Incidence rate of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of number of participants with axial length hortening greater than 0.10 mm and 0.20 mm to the total number. The IOL Master is used to measure axial length (mm).
Time Frame
12 months
Title
Magnitude of axial length shortening among shortened eyes
Description
Magnitude of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes. The IOL Master is used to measure axial length (mm).
Time Frame
12 months
Title
Changes in choroidal structural and perfusion parameters
Description
Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Swept-source optical coherence tomography and optical coherence tomography angiography are used to measure choroidal structural and perfusion parameters.
Time Frame
1, 3, 6 and 12 months
Title
Changes in retinal structures
Description
Swept-source optical coherence tomography is used to measure retinal structures.
Time Frame
1, 3, 6 and 12 months
Title
Changes in axial length and other biometric parameters
Description
The IOL Master is used to measure axial length and other biometric parameters, including corneal curvature, anterior chamber depth and white to white, etc. Change of each parameter is characterized as the difference between each follow-up visit and baseline values
Time Frame
1, 3, 6 and 12 months
Title
Change of cycloplegic spherical equivalent refraction (Diopter)
Description
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D)
Time Frame
1, 3, 6 and 12 months
Title
Change of pathologic myopia fundus META-PM grading
Description
The swept-source optical coherence tomography is used to obtain fundus images. The fundus images are classified based on META-PM classification system
Time Frame
1, 3, 6 and 12 months
Title
Change in best corrected visual acuity
Description
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. An Early Treatment Diabetic Retinopathy Study chart with standard illumination at a distance of 4 meters is used to measure best corrected visual acuity
Time Frame
1, 3, 6, and 12 months
Title
Incidence of self-reported adverse events
Description
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages
Time Frame
1, 3, 6 and 12 months
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:
Provision of consent.
Age: ≥ 6 and ≤ 16 years at enrolment.
High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
Willing and able to participate in all required activities of the study.
The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
Exclusion Criteria:
Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
Strabismus and binocular vision abnormalities in either eye.
Previous any intraocular surgery affecting refractive status.
Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangui He
Phone
021-62717733
Email
hxgcrco@shsyf.com
Facility Information:
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared as open data after proper anonymization.
Learn more about this trial
Repeated Low-Level Red-Light Therapy for Shortening Axial Length
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