Essilor® Stellest® Lenses Multicentre European Study (SLOMES) (NCT06263946) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)
France, Ireland, Netherlands150 participantsStarted 2024-03-22
Plain-language summary
The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the 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.
Who can participate
Age range6 Years – 16 Years
SexALL
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Inclusion criteria
âś“. \- Myopia as determined by cycloplegic autorefraction as follows:
âś“. \- Monocular corrected VA of at least 0.2 LogMAR in both eyes
âś“. \- Age: 6 - 16 years old, inclusive at the time of inclusion
âś“. \- Ability to understand treatment and give valid assent
âś“. \- Ability to comply with the protocol to get reliable study measurements
Exclusion criteria
âś•. \- Concomitant or previous therapies for myopia
âś•. \- Eye diseases/conditions:
âś•. \- Use of ocular or systemic medication which may affect myopia progression or visual acuity through known effects on retina, accommodation, or significant elevation of intraocular pressure
âś•. \- Participation in another study which may influence vision or interfere with study assessments