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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myopia

Intervention / Treatment
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* Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses
* Drug: Atropine 0.05% eyedrops
* Device: Monofocal lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of myopia - measured under cycloplegia - defined by: A sphere power between -1 and -6 Diopters, on at least one of the two eyes AND a cylindrical power strictly inferior to 2 Diopters 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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIMS®<br>Defocus Incorporated Multiple Segments® lenses | Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses<br>* 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.<br>* Other names: Miyosmart®;|
| Active Comparator: Low-concentration atropine + monofocal lenses<br> | Drug: Atropine 0.05% eyedrops<br>* One drop each evening in both eyes for 24 months.<br>* Other names: Low-concentration atropine;Device: Monofocal lenses<br>* Daily wear for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length measurements | Difference between the mean of 6 axial length measurements (in mm) acquired with the IOLMaster 500® at 24 months and the mean of 6 axial length measurements at inclusion | Inclusion, 24 months | 
| Spherical equivalent | Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion | Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Pediatric ophthalmology, Myopia control, Defocus Incorporated Multiple Segments (DIMS) lenses, Low concentration atropine