This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.
As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children. This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Test spectacle lenses will be provided to the subjects throughout the 1 year clinical trial.
Essilor R&D Centre
Singapore, Singapore
Axial length
Evaluate the change in axial length (mm)
Time frame: 12 months
Axial length
Evaluate change in axial length (mm)
Time frame: 6 months
Spherical Equivalent Refraction
Evaluate change in Spherical Equivalent Refraction (Diopters) through manifest subjective refraction
Time frame: 6 months, 12 months
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