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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Active, not recruiting

Conditions: Myopia

Treatments: Drug: Atropine 0.05% eyedrops; Device: Monofocal lenses; Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT05062031

GMN_2021_11

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

DIMS®

Experimental group

Description:

Defocus Incorporated Multiple Segments® lenses

Treatment:

Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses

Low-concentration atropine + monofocal lenses

Active Comparator group

Treatment:

Device: Monofocal lenses

Drug: Atropine 0.05% eyedrops