Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

November 29, 2024 updated by: Shanghai Eye Disease Prevention and Treatment Center

An Exploratory Study on the Minimum Power and Frequency of Repeated Low-level Red-light to Effectively Control Myopia Progression

To explore the minimum power and frequency of Repeated Low-level Red-light (RLRL) to control myopia progression in low-myopic children aged 8-10 years, and the rebound effect of low-myopic children after discontinuation of RLRL with different combinations of power and frequency.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Myopia has emerged as a significant public health concern in East Asia. The excessive elongation of the axial length ( AL)of the eye, particularly as myopia progresses to high myopia, is associated with mechanical stretching and thinning of the choroid and sclera. This can lead to vision-threatening complications such as myopic macular degeneration, macular hemorrhage, retinal detachment, cataracts, and glaucoma. Given the serious consequences of high myopia and its associated complications, early and effective prevention and control of myopia become a primary focus in safeguarding visual health and enhancing quality of life.

In recent years, RLRL holds significant potential as an effective strategy for preventing and controlling myopia in children and adolescents. However, recent researches prompt further questions: Is the current power of RLRL exposure optimal? Can the frequency of exposure be refined? What is the relationship among exposure power, frequency and myopia control? To explore these questions and clarify the effects of various combinations of exposure power and frequency on myopia progression following RLRL therapy, our research group plans to conduct a prospective, double-blind, single-center, randomized controlled clinical trial. This study aims to provide more comprehensive evidence to support this innovative intervention on myopia prevention and control.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200041
        • Recruiting
        • Shanghai Eye Disease Prevention & Treatment Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age: 8-10 years old
  2. Low myopia: cycloplegic spherical equivalent refractions (SERs) range from -0.50 (inclusive) to -3.00 diopters (D) and astigmatism less than -2.5 D in either eye.
  3. signed informed consent and was able to participate in the study

Exclusion Criteria:

  1. Secondary myopia, such as a history of retinopathy of prematurity or other neonatal diseases; syndromic myopia with a known genetic disorder or connective tissue disease, such as Stickler syndrome or Marfan syndrome
  2. Strabismus or other binocular vision abnormalities
  3. Cloudy refractive media: cloudy cornea, cataract or intraocular lens surgery
  4. Eye diseases that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
  5. History of refractive surgery, internal eye surgery, laser therapy, vitreous injection, etc.
  6. diabetes, hypertension and other systemic disorders
  7. History of use of retinal toxic drugs, such as hydroxychloroquine, etc.
  8. Use of orthokeratology, atropine, multifocal frame glasses and other myopia control methods; children who are currently receiving atropine, orthokeratology, multifocal frame glasses and other myopia control treatment, can be enrolled after 2 weeks of treatment.
  9. Other reasons considered unsuitable for inclusion by the study physician, including but not limited to other ocular and systemic disease abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Red light: 2.0 mW/twice daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 2.0 mW/once daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 1.0 mW/twice daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 1.0 mW/once daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 0.5 mW/twice daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 0.5 mW/once daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 0.3 mW/twice daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Experimental: Red light: 0.3 mW/once daily
Device: Repeated Low-level Red-light
In addition to single vision spectacle lenses (SVS) with power for correcting distance refraction, the subjects used the prescribed power low-intensity red light treatment instrument for the prescribed number of treatments from Monday to Friday, with a 3-minute interval of 4 hours.
Sham Comparator: Red LED: twice daily
Device: Red LED
In addition to SVS with power for correcting distance refraction, red LED 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
The incidence (%) of axial length increase ≤0.05mm after red light for 3 months measured by the IOL master
Time Frame: 1 week, 1, 2, 3 months
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.
1 week, 1, 2, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rates (%) of cycloplegic spherical equivalent refraction progressing ≥0.00 D after red light for 3 months measured by the autorefractor
Time Frame: 1 week, 1, 2, 3 months
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).
1 week, 1, 2, 3 months
Changes of axial length (mm) after discontinuation of red light for 1 months measured by the IOL master
Time Frame: 4 months
Change of axial length is characterized as the difference between each follow-up visit and baseline values.
4 months
Changes of cycloplegic spherical equivalent refraction (D) after discontinuation of red light for 1 months measured by the autorefractor
Time Frame: 4 months
Change of cycloplegic spherical equivalent refraction is characterized as the difference between each follow-up visit and baseline values.
4 months
Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
Time Frame: 1 week, 1, 2, 3, 4 months
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects.
1 week, 1, 2, 3, 4 months
Change in visual acuity (logMAR) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Time Frame: 1 week, 1, 2, 3, 4 months
Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart with standard illumination at a distance of 4 meters is used to measure visual acuity.
1 week, 1, 2, 3, 4 months
Changes in choroidal thickness (μm) measured by the swept-source optical coherence tomography and optical coherence tomography angiography
Time Frame: 1 week, 1, 2, 3, 4 months
Changes in choroidal thickness (μm) are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on.
1 week, 1, 2, 3, 4 months
Changes in the amplitudes of waves (mV) measured by the full-filed electroretinogram
Time Frame: 1 week, 1, 2, 3, 4 months
Changes in the amplitudes of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
1 week, 1, 2, 3, 4 months
Changes in the the latency of waves (ms) measured by the full-filed electroretinogram
Time Frame: 1 week, 1, 2, 3, 4 months
Changes in the latecy of the waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.
1 week, 1, 2, 3, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 9, 2024

Primary Completion (Estimated)

April 9, 2025

Study Completion (Estimated)

June 9, 2025

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLPT-SEPTC-2024

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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