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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses; Drug: Atropine 0.05% eyedrops; Device: Monofocal lenses

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Ecouter Voir; Hoya Lens France
• Investigators: Principal Investigator: Gilles MARTIN, MD, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Myopia; Myopia control; Pediatric ophthalmology; Defocus Incorporated Multiple Segments (DIMS) lenses; Low concentration atropine
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Pharmaceutical Solutions; Organic Chemicals; Heterocyclic Compounds; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Alkaloids; Equipment and Supplies; Optical Devices; Solutions; Specialty Uses of Chemicals; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine; Ophthalmic Solutions; Lenses
• Other Study ID Numbers: GMN_2021_11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No