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

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Defocus Incorporated Multiple Segments® (DIMS®) lenses
Atropine 0.05% eyedrops
Monofocal lenses
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Pediatric ophthalmology, Myopia control, Defocus Incorporated Multiple Segments (DIMS) lenses, Low concentration atropine

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Fondation Adolphe de RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DIMS®

Low-concentration atropine + monofocal lenses

Arm Description

Defocus Incorporated Multiple Segments® lenses

Outcomes

Primary Outcome Measures

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
Spherical equivalent
Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
October 4, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Ecouter Voir, Hoya Lens France
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1. Study Identification

Unique Protocol Identification Number
NCT05062031
Brief Title
Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Ecouter Voir, Hoya Lens France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Pediatric ophthalmology, Myopia control, Defocus Incorporated Multiple Segments (DIMS) lenses, Low concentration atropine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DIMS®
Arm Type
Experimental
Arm Description
Defocus Incorporated Multiple Segments® lenses
Arm Title
Low-concentration atropine + monofocal lenses
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Defocus Incorporated Multiple Segments® (DIMS®) lenses
Other Intervention Name(s)
Miyosmart®
Intervention Description
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
Drug
Intervention Name(s)
Atropine 0.05% eyedrops
Other Intervention Name(s)
Low-concentration atropine
Intervention Description
One drop each evening in both eyes for 24 months.
Intervention Type
Device
Intervention Name(s)
Monofocal lenses
Intervention Description
Daily wear for 24 months
Primary Outcome Measure Information:
Title
Axial length measurements
Description
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
Time Frame
Inclusion, 24 months
Title
Spherical equivalent
Description
Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion
Time Frame
Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie YAVCHITZ, MD
Phone
+33148036433
Email
ayavchitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles MARTIN, MD
Email
gmartin@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MARTIN, MD
Organizational Affiliation
Hôpital Fondation Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Fondation Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles MARTIN
Email
gmartin@for.paris
First Name & Middle Initial & Last Name & Degree
Pauline BEAUJEUX
Email
pbeaujeux@for.paris

12. IPD Sharing Statement

Learn more about this trial

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

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