NCT05888792

Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes

Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Detailed description

The variant of Defocus Incorporated Spectacle lenses (D2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time. Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for another 36 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 4 years. The changes in refractive errors and axial length in two groups will be compared.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	Variant of Defocus Incorporated Spectacle lens (DG2)	DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously

Timeline

• Start date: 2023-07-29
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2023-06-05
• Last updated: 2026-03-02

Locations

1 site across 1 country: Hong Kong