Clinical trial NCT05062031: Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Pediatric ophthalmology
Myopia control
Defocus Incorporated Multiple Segments (DIMS) lenses
Low concentration atropine
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Ecouter Voir
name: Hoya Lens France
First posted: 2021-09-30
Enrollment: 242
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Axial length measurements
timeFrame: Inclusion, 24 months
measure: Spherical equivalent
timeFrame: Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild
name: Gilles MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: