Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control

The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy

The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.

Study Overview

• Status: Active, not recruiting
• Conditions: Eye Diseases; Refractive Errors; Myopia
• Intervention / Treatment: Device: Low-level Red-light Therapy

Detailed Description

Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • The Second People's Hospital Of Foshan
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518038
      • Shenzhen Children's Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age at enrolment: 8-13 years
2. Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
3. Astigmatism of 2.50 D or less
4. Anisometropia of 1.5 D or less
5. Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
6. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

1. Strabismus and binocular vision abnormalities in either eye
2. Ocular abnormalities in either eye or other systemic abnormalities
3. Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
4. Other contraindications in either eye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Single vision spectacle lens; Single vision lens with power for correcting distance refraction.
Experimental: Repeated low-level red-light therapy; Single vision lens & repeated low-level red-light therapy	Device: Low-level Red-light Therapy; In addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length change (mm)	Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).	1 month, 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycloplegic spherical equivalent change (Diopter)	Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Cycloplegia is induced with one drop of Alcaine 0.5% followed by two drops of 1% cyclopentolate administered at 0, 5th to each eye. The third drop of cyclopentolate is used if the light reflex exists after 20 minute. The light reflex and pupil dilation is checked after an additional 15 minutes. Dilation and light reflex status is recorded and full cycloplegia is justified if the pupil dilates to 6 millimeters or greater and the light reflex is absent. Refraction is performed with an auto-refractor. The data on spherical and cylindrical power and axis is automatically extracted from the auto-refractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).	1 month, 3 months, 6 months and 1 year
Corneal curvature change (mm)	Corneal curvature (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure corneal curvature (mm).	1 month, 3 months, 6 months and 1 year
Anterior chamber depth change (mm)	Anterior chamber depth (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure anterior chamber depth (mm).	1 month, 3 months, 6 months and 1 year
White to white change (mm)	White to white (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure white to white (mm).	1 month, 3 months, 6 months and 1 year
Visual acuity change	Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart (Precision vision, Villa Park, Illinois, USA) with standard illumination is used to measure distance visual acuity. Visual acuity measurement is performed at a distance of 4 meters. Uncorrected visual acuity is measured for all children.	1 month, 3 months, 6 months and 1 year
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	1 month
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	3 months
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	6 months
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length change (mm)	Axial length change (mm) is characterized as the difference between 2-year follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).	2 years
Cycloplegic spherical equivalent change (Diopter)	Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between 2-year follow-up visit and baseline values. Cycloplegia is induced with one drop of Alcaine 0.5% followed by two drops of 1% cyclopentolate administered at 0, 5th to each eye. The third drop of cyclopentolate is used if the light reflex exists after 20 minute. The light reflex and pupil dilation is checked after an additional 15 minutes. Dilation and light reflex status is recorded and full cycloplegia is justified if the pupil dilates to 6 millimeters or greater and the light reflex is absent. Refraction is performed with an auto-refractor. The data on spherical and cylindrical power and axis is automatically extracted from the auto-refractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D).	2 years
Visual acuity change	Visual acuity change is characterized as the difference between 2-year follow-up visit and baseline values. An ETDRS chart (Precision vision, Villa Park, Illinois, USA) with standard illumination is used to measure distance visual acuity. Visual acuity measurement is performed at a distance of 4 meters. Uncorrected visual acuity is measured for all children.	2 years
Changes in other ocular parameters	The IOLMaster is used to measure ocular parameters (e.g., corneal curvature change). Change of each parameter is characterized as the difference between its 2-year follow-up visit and baseline values.	2 years
Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over a specified period for subjects in the intervention arm. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.	2 years

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: Xiangya Hospital of Central South University; Shenzhen Children's Hospital; The Second People's Hospital of Foshan
• Investigators: Principal Investigator: Mingguang He, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Xiong R, Zhu Z, Jiang Y, Wang W, Zhang J, Chen Y, Bulloch G, Yuan Y, Zhang S, Xuan M, Zeng J, He M. Longitudinal changes and predictive value of choroidal thickness for myopia control following repeated low-level red-light therapy. Ophthalmology. 2022 Oct 11:S0161-6420(22)00780-1. doi: 10.1016/j.ophtha.2022.10.002. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 18, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Myopia
• Other Study ID Numbers: 2019KYPJ093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

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