Myopia nearsightedness
Conditions
Interventions
Sponsors
Essilor International
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1 - Myopia as determined by cycloplegic autorefraction as follows: - Each meridian SER of plano to - 8;00 D in each eye - Astigmatism
Exclusion criteria
Exclusion criteria: 1 - Concomitant or previous therapies for myopia 2 - Eye diseases/conditions: - Strabismus by cover test at near or distance - Any ocular disease that would influence refractive development - Any systemic or neurodevelopmental conditions that may influence refractive development 3 - Use of ocular or systemic medication which may affect myopia progression or visual acuity 4 - Participation in another study which may influence vision or interfere with study assessments 5 - Myopia onset before 5 years of age 6 - Contact lens wearers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in axial length and cycloplegic autorefraction from baseline to 12 and 24 months compared to expected change based on axial length and refraction centile positions at baseline. • Change in refraction progression centile from 12 months to 24 months visits. • Change in refraction compared to that observed in control group participants during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study, a contemporaneous (ongoing) myopia control trial conducted in Ireland from 2019 to 2023. • Change in axial length compared to that observed in control group participants during the first and second year (separate comparisons for each year) of the MOSAIC study. • Change in choroidal thickness compared to that observed in control group participants during the first and second year (separate comparisons for each year) of the MOSAIC study. • Change in refraction compared to children treated with 0.01% atropine during the first and second year (separate comparisons for each year) of the MOSAIC study. • Change in axial length compared to children treated with 0.01% atropine during the first and second year (separate comparisons for each year) of the MOSAIC study. • Change in choroidal thickness compared to children treated with 0.01% atropine during the first and second year (separate comparisons for each year) of the MOSAIC study. • Change in Paediatric Refractive Error Profile (PREP-2) score from baseline (pre-Stellest®) to 12 and 24 months (post-Stellest ®). • Incidence of adverse and serious adverse events over the course of the study. • Treatment adaptation, acceptability, and compliance to the Essilor® Stellest® spectacle lenses, assessed using questionnaires at each post-baseline study visit. • Quality of life questionnaire (PREP-2) | — |
Countries
Netherlands
Outcome results
None listed