NCT04923841

Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

Effectiveness of Bright Light Therapy, Myopic Defocus, Atropine and the Combinations for Controlling Myopic Eye Growth in Schoolchildren: A Randomized Control Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 579 (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 effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

Detailed description

The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy. Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had 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. The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	High intensity light box for bright light therapy and single vision spectacle lenses	High intensity light box for bright light therapy and single vision spectacle lenses
OTHER	High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses	High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
OTHER	High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses	High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
OTHER	Atropine 0.01% eye drop and and single vision spectacle lenses	Atropine 0.01% eye drop and and single vision spectacle lenses

Timeline

• Start date: 2021-09-09
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2021-06-11
• Last updated: 2026-03-02

Locations

1 site across 1 country: Hong Kong