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

NCT05062031 | Active Not Recruiting

• 1 other identifier: GMN_2021_11
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

Myopia; Pediatric ophthalmology; Myopia control; Defocus Incorporated Multiple Segments (DIMS) lenses; Low concentration atropine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

DIMS®

EXPERIMENTAL

Defocus Incorporated Multiple Segments® lenses

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

Low-concentration atropine + monofocal lenses

ACTIVE COMPARATOR

Drug: Atropine 0.05% eyedrops; Device: Monofocal lenses

Interventions

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.

Also known as: Miyosmart®

DIMS®

Atropine 0.05% eyedrops DRUG

One drop each evening in both eyes for 24 months.

Also known as: Low-concentration atropine

Low-concentration atropine + monofocal lenses

Monofocal lenses DEVICE

Daily wear for 24 months

Low-concentration atropine + monofocal lenses

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Ecouter Voir: collaborator
• Hoya Lens France: collaborator

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Myopia

Interventions

Lenses; Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Gilles MARTIN, MD

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 30, 2021
• Study Start: October 19, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)