The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses. A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group). They must have no prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine. Their cycloplegic refraction and axial length will be monitored every six months for 18 months. The changes in refractive errors and axial length between groups will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants.
Single vision spectacle lenses will be given to this group of participants.
0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.
Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong
Hong Kong, Hong Kong
Changes in cycloplegic refraction
Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured.
Time frame: Baseline, 6th month, 12th month and 18th month
Changes in axial length
Changes in axial length (mm) over 18 months from baseline will be measured.
Time frame: Baseline, 6th month, 12th month and 18th month
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