NCT06358755

Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control

Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Defocus Incorporated Multiple Segments lenses	Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants.
DEVICE	single vision spectacle lenses	Single vision spectacle lenses will be given to this group of participants.
DRUG	Low dose atropine	0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.

Timeline

• Start date: 2024-07-12
• Primary completion: 2026-05-30
• Completion: 2027-01-31
• First posted: 2024-04-11
• Last updated: 2026-03-02

Locations

1 site across 1 country: Hong Kong