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

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses; Drug: Atropine 0.05% eyedrops; Device: Monofocal lenses

• Registration Number: NCT05062031
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-30
• Study Start: 2021-10-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 242

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIMS®	Defocus Incorporated Multiple Segments® (DIMS®) lenses	Defocus Incorporated Multiple Segments® lenses
Low-concentration atropine + monofocal lenses	Atropine 0.05% eyedrops	-
Low-concentration atropine + monofocal lenses	Monofocal lenses	-

Primary Outcome Measures

Name	Time	Method
Axial length measurements	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
Spherical equivalent	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

Trial Locations

Locations (1)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France