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

NCT ID: NCT05062031

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DIMS®

Defocus Incorporated Multiple Segments® lenses

Group Type: EXPERIMENTAL

Defocus Incorporated Multiple Segments® (DIMS®) lenses

Intervention Type: 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.

Low-concentration atropine + monofocal lenses

Group Type: ACTIVE_COMPARATOR

Atropine 0.05% eyedrops

Intervention Type: DRUG

One drop each evening in both eyes for 24 months.

Monofocal lenses

Intervention Type: DEVICE

Daily wear for 24 months

Interventions

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.

Intervention Type: DEVICE

Atropine 0.05% eyedrops

One drop each evening in both eyes for 24 months.

Intervention Type: DRUG

Monofocal lenses

Daily wear for 24 months

Intervention Type: DEVICE

Other Intervention Names

Miyosmart®; Low-concentration atropine

Eligibility Criteria

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecouter Voir

UNKNOWN

Sponsor Role: collaborator

Hoya Lens France

UNKNOWN

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles MARTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Locations

Hôpital Fondation Adolphe de Rothschild

Paris, , France

Countries

France

Other Identifiers

GMN_2021_11

Identifier Type: -

Identifier Source: org_study_id