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

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Sep 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help control myopia, or nearsightedness, in children. The researchers want to compare the effectiveness of special glasses called Defocus Incorporated Multiple Segments® (DIMS®) lenses against using atropine eyedrops along with regular glasses. Myopia is common among kids, and while atropine drops have been useful, they can have some limitations, such as availability and varying responses in children. By comparing these two approaches over two years, the trial hopes to find out which one works better in slowing down the growth of the eye, which can lead to worsening myopia.

To participate in this study, children aged between 4 and 12 years old who have myopia and have never tried other myopia control methods may be eligible. Parents need to provide written consent for their child to join. Throughout the trial, participants will wear the assigned lenses or use the eyedrops and will be monitored for changes in their eyesight. It’s important for families to know that children with certain eye conditions or a history of severe allergic reactions may not qualify for the study.

Gender

ALL

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)