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Clinical Trial Summary

The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06358755
Study type Interventional
Source The Hong Kong Polytechnic University
Contact Rachel Ka Man Chun, PhD
Phone +852-27664224
Email rachel.chun@polyu.edu.hk
Status Not yet recruiting
Phase Phase 2
Start date May 1, 2024
Completion date October 31, 2026

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