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OpenTrials
Completed

NCT Number: NCT05062031

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Defocus Incorporated Multiple Segments® (DIMS®) lenses

Device

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.

Other names: Miyosmart®

Atropine 0.05% eyedrops

Drug

One drop each evening in both eyes for 24 months.

Other names: Low-concentration atropine

Monofocal lenses

Device

Daily wear for 24 months

Primary outcomes

  1. Axial length measurements

    Time frame: Inclusion, 24 months

    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

  2. Spherical equivalent

    Time frame: Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months

    Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • Ecouter Voir
  • Hoya Lens France

Registry information

Official study title

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

Acronym: ATROSMART

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2021
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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