The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment. The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
RLRL will be performed twice per day with an interval of at least 4 hours, each treatment last 3 minutes, in addition to single vision spectacles with power for correcting distance refraction.
The Second People's Hospital of Foshan
Foshan, Guangdong, China
Incidence rate of axial length shortening greater than 0.05 mm
Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Time frame: 12 months
Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
Incidence rates of axial length shortening \> 0.10 mm and 0.20 mm are characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.10 mm and 0.20 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
Time frame: 12 months
Magnitude of axial length shortening among shortened eyes
The magnitude of axial length shortening is characterized as the amount of axial length reduction in eyes with axial shortening. Axial length (mm) is measured using the IOL Master.
Time frame: 12 months
Changes in choroidal thickness (μm)
Changes in choroidal thickness are characterized as the difference between each follow-up visit and corresponding baseline values which are measured using the optical coherence tomography.
Time frame: 1, 3, 6 and 12 months
Changes in axial length (mm)
Changes of axial length is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time frame: 1, 3, 6 and 12 months
Changes in corneal curvature (mm)
Changes of corneal curvature is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
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Time frame: 1, 3, 6 and 12 months
Changes in anterior chamber depth (mm)
Changes of anterior chamber depth is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time frame: 1, 3, 6 and 12 months
Changes in white to white (mm)
Changes of white to white is characterized as the difference between each follow-up visit and baseline values which are measured using the IOL Master.
Time frame: 1, 3, 6 and 12 months
Change of cycloplegic spherical equivalent refraction
Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. 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).
Time frame: 1, 3, 6 and 12 months
Change of pathologic myopia fundus META-PM grading
The fundus images are classified based on META-PM classification system. Color fundus images are obtained using the fundus camera.
Time frame: 1, 3, 6 and 12 months
Change in best corrected visual acuity
Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. Visual acuity is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart with standard illumination at a distance of 4 meters.
Time frame: 1, 3, 6 and 12 months
Incidence of self-reported adverse events
Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages.
Time frame: 1, 3, 6 and 12 months