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

Not Applicable

• Conditions: Myopia; Eye Diseases; Refractive Errors
• Interventions: Device: Low-level Red-light Therapy

• Registration Number: NCT04073238
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study Start: 2019-07-23
• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated low-level red-light therapy	Low-level Red-light Therapy	Single vision lens \& repeated low-level red-light therapy

Primary Outcome Measures

Name	Time	Method
Axial length change (mm)	1 month, 3 months, 6 months and 1 year	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).

Secondary Outcome Measures

Name	Time	Method
Cycloplegic spherical equivalent change (Diopter)	1 month, 3 months, 6 months and 1 year	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).
Corneal curvature change (mm)	1 month, 3 months, 6 months and 1 year	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).
Anterior chamber depth change (mm)	1 month, 3 months, 6 months and 1 year	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).
White to white change (mm)	1 month, 3 months, 6 months and 1 year	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).
Visual acuity change	1 month, 3 months, 6 months and 1 year	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.
Incidence of treatment-emergent adverse events	1 year	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.

Trial Locations

Locations (4)

Shenzhen Children's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The Second People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China