Clinical trial NCT04073238: Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control
Official title: The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Refractive Errors
Eye Diseases
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Children's Hospital
name: The Second People's Hospital of Foshan
name: Xiangya Hospital of Central South University
First posted: 2019-08-29
Enrollment: 264
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Axial length change (mm)
timeFrame: 1 month, 3 months, 6 months and 1 year
Secondary outcomes:
measure: Cycloplegic spherical equivalent change (Diopter)
timeFrame: 1 month, 3 months, 6 months and 1 year
measure: Corneal curvature change (mm)
timeFrame: 1 month, 3 months, 6 months and 1 year
measure: Anterior chamber depth change (mm)
timeFrame: 1 month, 3 months, 6 months and 1 year
measure: White to white change (mm)
timeFrame: 1 month, 3 months, 6 months and 1 year
measure: Visual acuity change
timeFrame: 1 month, 3 months, 6 months and 1 year
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 month
measure: Incidence of treatment-emergent adverse events
timeFrame: 3 months
measure: Incidence of treatment-emergent adverse events
timeFrame: 6 months
measure: Incidence of treatment-emergent adverse events
timeFrame: 1 year
Other outcomes:
measure: Axial length change (mm)
timeFrame: 2 years
measure: Cycloplegic spherical equivalent change (Diopter)
timeFrame: 2 years
measure: Visual acuity change
timeFrame: 2 years
measure: Changes in other ocular parameters
timeFrame: 2 years
measure: Incidence of treatment-emergent adverse events
timeFrame: 2 years
Locations:
city: Foshan
country: China
facility: The Second People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Mingguang He, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 after Repeated Low-Level Red-Light Therapy. Ophthalmology. 2023 Mar;130(3):286-296. doi: 10.1016/j.ophtha.2022.10.002. Epub 2022 Oct 11.