Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure

Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Refractive Errors; Myopia; Retina; Change
• Intervention / Treatment: Device: RLRL

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20041
      • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 15-16 years at enrolment.
2. 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.
3. Best corrected visual acuity equal to or better than 0.8 in either eye.
4. Normal fundus, or tessellated fundus.
5. Provision of consent and able to participate in all required activities of the study.

Exclusion Criteria:

1. 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.
2. Strabismus and binocular vision abnormalities in either eye.
3. Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
4. Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
6. Systemic abnormalities: diabetes, hypertension, etc.
7. Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
8. Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
9. Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repeated Low-Level Red-Light Therapy (RLRL); Single vision spectacles (SVS) & RLRL.	Device: RLRL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 and 2 months
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.	1 and 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months
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.	1 and 2 months

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: RLS-SEPTC-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared as open data after proper anonymization.

Drug and device information, study documents

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