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

Last updated: February 11, 2025
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Myopia

Treatment

Atropine 0.05% eyedrops

Monofocal lenses

Defocus Incorporated Multiple Segments® (DIMS®) lenses

Clinical Study ID

NCT05062031
GMN_2021_11
  • Ages 4-14
  • All Genders

Study 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 Criteria

Inclusion

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 flattestaxis

  • 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

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 onone of the two eyes

  • Anisometropia defined by a difference of 2 Diopters or more between the two eyes (inspherical 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 oftreatment (including vernal keratoconjunctivitis)

Study Design

Total Participants: 242
Treatment Group(s): 3
Primary Treatment: Atropine 0.05% eyedrops
Phase:
Study Start date:
October 19, 2021
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Hôpital Fondation Adolphe de Rothschild

    Paris, 75019
    France

    Site Not Available

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