NCT05062031

Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

Comparison of Defocus Incorporated Multiple Segments® (DIMS®) Lenses Alone Versus Monofocal Lenses + Atropine 0.05% Eyedrops on the Evolution of Ocular Axial Length at 2 Years in Myopia Control in Children: Single-centre Prospective Randomised Controlled 1:1 Open-label Non-inferiority Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation. Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses. The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Defocus Incorporated Multiple Segments® (DIMS®) lenses	Daily wear for 24 months. Lenses have a central monofocal optical zone correcting spherical or spherocylindrical ametropia, surrounded by a ring made up of 300 defocusing pellets. This lens geometry reduces the phenomenon of blurred image projected in the retinal periphery, encountered when myopic eyes are corrected with monofocal lenses.
DRUG	Atropine 0.05% eyedrops	One drop each evening in both eyes for 24 months.
DEVICE	Monofocal lenses	Daily wear for 24 months

Timeline

• Start date: 2021-10-19
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2021-09-30
• Last updated: 2025-12-10

Locations

1 site across 1 country: France