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

Myopia Clinical Trial

— ATROSMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062031
• Other study ID #: GMN_2021_11
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: October 2026

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ, MD
• Phone: +33148036433
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• 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.

Drug:
• Atropine 0.05% eyedrops
One drop each evening in both eyes for 24 months.

Device:
• Monofocal lenses
Daily wear for 24 months

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Ecouter Voir, Hoya Lens France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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