Back to resultsEffect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
Primary Purpose
Myopia, Refractive Errors, Eye Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RLRL
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Age: 15-16 years at enrolment.
- Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
- Best corrected visual acuity equal to or better than 0.8 in either eye.
- Normal fundus, or tessellated fundus.
- Provision of consent and able to participate in all required activities of the study.
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.
- Strabismus and binocular vision abnormalities in either eye.
- Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
- Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
- Systemic abnormalities: diabetes, hypertension, etc.
- Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
- Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
- Other contraindications, 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 CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Repeated Low-Level Red-Light Therapy (RLRL)
Arm Description
Single vision spectacles (SVS) & RLRL.
Outcomes
Primary Outcome Measures
Changes in the amplitudes of waves.
Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Changes in the latency of waves.
Changes in the latency of waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Secondary Outcome Measures
Changes in retinal sensitivity
Changes in retinal sensitivity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Changes in fixation stability
Changes in fixation stability are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Changes in macular integrity
Changes in macular integrity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Changes in macular vessel density
Changes in macular vessel density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Changes in macular perfusion density
Changes in macular perfusion density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Changes in chorocapillaris flow defict percentage
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Changes in choroidal vascularity index
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography.
Changes in best corrected visual acuity
Best corrected visual acuity changes are 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.
Full Information
NCT ID
NCT05597397
First Posted
September 20, 2022
Last Updated
April 5, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT05597397
Brief Title
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
Official Title
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 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 evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.
Detailed Description
Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. A previous randomized clinical trial suggested that RLRL could effectively controlled myopia progression without clinically observable side effects.
The purpose of this study is to evaluate the effect of RLRL on the retinal function and structure among myopic teenagers aged 15-16 years. The RLRL therapy will be carried out at school under supervision of the parents according to a standard protocol for the first month and then will be discontinued for 1 month. Detailed functional and structural examinations, including full field electroretinogram, multifocal electroretinogram, microperimetry, visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, and biological parameters will be evaluated at 1 month, 2 months after enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors, Eye Diseases, Retina; Change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeated Low-Level Red-Light Therapy (RLRL)
Arm Type
Experimental
Arm Description
Single vision spectacles (SVS) & RLRL.
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
Changes in the amplitudes of waves.
Description
Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Time Frame
1 and 2 months
Title
Changes in the latency of waves.
Description
Changes in the latency of waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
Time Frame
1 and 2 months
Secondary Outcome Measure Information:
Title
Changes in retinal sensitivity
Description
Changes in retinal sensitivity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Time Frame
1 and 2 months
Title
Changes in fixation stability
Description
Changes in fixation stability are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Time Frame
1 and 2 months
Title
Changes in macular integrity
Description
Changes in macular integrity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry.
Time Frame
1 and 2 months
Title
Changes in macular vessel density
Description
Changes in macular vessel density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Time Frame
1 and 2 months
Title
Changes in macular perfusion density
Description
Changes in macular perfusion density are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Time Frame
1 and 2 months
Title
Changes in chorocapillaris flow defict percentage
Description
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography angiography.
Time Frame
1 and 2 months
Title
Changes in choroidal vascularity index
Description
Changes in choroidal vascularity index are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by optical coherence tomography.
Time Frame
1 and 2 months
Title
Changes in best corrected visual acuity
Description
Best corrected visual acuity changes are 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 and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 15-16 years at enrolment.
Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
Best corrected visual acuity equal to or better than 0.8 in either eye.
Normal fundus, or tessellated fundus.
Provision of consent and able to participate in all required activities of the study.
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.
Strabismus and binocular vision abnormalities in either eye.
Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
Systemic abnormalities: diabetes, hypertension, etc.
Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
Other contraindications, 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, PhD
Phone
+862153555032
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
Individual Site Status
Recruiting
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
Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
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