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

GMN_2021_11

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.

2021-10-19

2026-10-01

2026-10-01

Recruiting

242

Inclusion Criteria: * Diagnosis of myopia - measured under cycloplegia - defined by: 1. A sphere power between -1 and -6 Diopters, on at least one of the two eyes 2. AND a cylindrical power strictly inferior to 2 Diopters 3. AND a maximum refractive error strictly inferior to 8 Diopters in the flattest axis * Not benefiting and never having benefited from a myopia control strategy (orthokeratology, soft defocusing lenses, low concentration atropine eye drops, peripheral defocusing corrective lenses) * Written consent of both parents Exclusion Criteria: * History of genetic disease, or general condition suggesting a syndromic myopia (including an axial length greater than 27 mm) * Strabismus * Amblyopia defined by a best corrected visual acuity strictly inferior to 10/10 on one of the two eyes * Anisometropia defined by a difference of 2 Diopters or more between the two eyes (in spherical equivalent) * History of allergy to atropine * History of severe anaphylaxis * Optical correction with contact lenses * Previous ophthalmologic surgery of the cornea, lens, retina * History of glaucoma or any other chronic ophthalmological disease in the course of treatment (including vernal keratoconjunctivitis)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 242, 'type': 'ESTIMATED'}}

2023-10-05