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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT05062031

Collaborator

HOYA Lamphun Ltd (Industry), Ecouter Voir (Other)

242

Enrollment

Location

Arms

59.4

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Defocus Incorporated Multiple Segments® (DIMS®) lenses Drug: Atropine 0.05% eyedrops Device: Monofocal lenses	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

242 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DIMS® Defocus Incorporated Multiple Segments® lenses	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. Other Names: Miyosmart®
Active Comparator: Low-concentration atropine + monofocal lenses	Drug: Atropine 0.05% eyedrops One drop each evening in both eyes for 24 months. Other Names: Low-concentration atropine Device: Monofocal lenses Daily wear for 24 months

Arm

Intervention/Treatment

Experimental: DIMS®

Defocus Incorporated Multiple Segments® lenses

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.

Other Names:

Miyosmart®

Active Comparator: Low-concentration atropine + monofocal lenses

Drug: Atropine 0.05% eyedrops

One drop each evening in both eyes for 24 months.

Other Names:

Low-concentration atropine

Device: Monofocal lenses

Daily wear for 24 months

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of myopia - measured under cycloplegia - defined by:

A sphere power between -1 and -6 Diopters, on at least one of the two eyes
AND a cylindrical power strictly inferior to 2 Diopters
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)