protocolSection identificationModule nctId: NCT06263946, orgStudyIdInfo id: WS10337, briefTitle: Essilor® Stellest® Lenses Multicentre European Study (SLOMES), acronym: SLOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Essilor International, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: multicentre, European, prospective, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Essilor® Stellest® spectacle lenses, outcomesModule primaryOutcomes measure: Change in cycloplegic axial length, primaryOutcomes measure: Change in cycloplegic autorefraction, secondaryOutcomes measure: Change in refraction progression centile, secondaryOutcomes measure: Change in cycloplegic axial length, secondaryOutcomes measure: Change in cycloplegic autorefraction, secondaryOutcomes measure: Change in refraction, secondaryOutcomes measure: Change in axial length, secondaryOutcomes measure: Change in choroidal thickness, secondaryOutcomes measure: Change in refraction, secondaryOutcomes measure: Change in axial length vs atropine, secondaryOutcomes measure: Change in choroidal thickness, secondaryOutcomes measure: Change in Paediatric Refractive Error Profile (PREP-2) score, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department, status: RECRUITING, city: Paris, zip: 75019, country: France, contacts name: Ramin Tadayoni, Professor, role: CONTACT, email: rtadayoni@for.paris, contacts name: Ramin Tadayoni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Centre for Eye Research Ireland (CERI) - TU DUBLIN, status: RECRUITING, city: Dublin, zip: D07 H6K8, country: Ireland, contacts name: Ian Flitcroft, Professor, role: CONTACT, email: ian.flitcroft@tudublin.ie, contacts name: James LOUGHMAN, Professor, role: CONTACT, phone: +353868589593, email: james.loughman@tudublin.ie, contacts name: Ian Flitcroft, Pr., role: PRINCIPAL_INVESTIGATOR, contacts name: James Loughman, Pr., role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Erasmus Medical Center, status: NOT_YET_RECRUITING, city: Rotterdam, zip: 3015, country: Netherlands, contacts name: Caroline Klaver, Professor, role: CONTACT, email: c.c.w.klaver@erasmusmc.nl, contacts name: Jan Roelof Polling, role: CONTACT, phone: 010-7040704, email: j.polling@erasmusmc.nl, contacts name: Caroline Klaver, role: PRINCIPAL_INVESTIGATOR, contacts name: Jan Roelof Polling, role: SUB_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False