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

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

NCT05062031•Fondation Ophtalmologique Adolphe de Rothschild

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 14 years

Sex

ALL

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)

Locations (1)

Hôpital Fondation Adolphe de Rothschild

Paris, France

Key Dates

Start Date

October 19, 2021

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

December 10, 2025

Enrollment

242

ESTIMATED participants

Conditions

Myopia

Interventions

Defocus Incorporated Multiple Segments® (DIMS®) lenses

DEVICE

Atropine 0.05% eyedrops

DRUG

Monofocal lenses

DEVICE

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

NCT07078799

MyopiaAstigmatism

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RECRUITINGPHASE3

Atropine in the Treatment of Myopia Study in Malaysia

NCT07329777

Myopia Progression

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RECRUITINGNA

Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

Atropine in the Treatment of Myopia Study in Malaysia

Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression

China Axial Length Study

Study Comparing Eye Growth Over Time in Children Using Two Myopia Control Lenses

Clinical Evaluation of WaveLight Plus LASIK