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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Collaborators: Ecouter Voir; HOYA Lamphun Ltd
• Treatments: Atropine; Ophthalmic Solutions

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)