Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

N/AActive Not RecruitingNCT06263946

Essilor International150 enrolled

Overview

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.

The trial design is a multicentre, European, prospective, interventional study with single group assignment. The investigational medical device Essilor® Stellest® is a CE marked, myopia control spectacle lens. The trial period for all participants is 24 months. The recruiting period is 6 to 9 months depending on countries / sites for a total of 150 participants (50 in Ireland, 75 in France and 25 in The Netherlands). The secondary objectives are: * To evaluate the acceptability of Essilor® Stellest® spectacle lenses in slowing myopia progression. * To evaluate the quality-of-life implications for children and adolescents. * To evaluate the safety of Essilor® Stellest® spectacle lenses in slowing myopia progression. * To evaluate the effect of Essilor® Stellest® spectacle lenses on choroidal thickness.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Myopia

Interventions

Essilor® Stellest® spectacle lensesDEVICE

patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. \- Myopia as determined by cycloplegic autorefraction as follows: * Each meridian SER of plano to - 8;00 D in each eye * Astigmatism \< 2.50 D * Anisometropia ≤ 1.50 D 2. \- Monocular corrected VA of at least 0.2 LogMAR in both eyes 3. \- Age: 6 - 16 years old, inclusive at the time of inclusion 4. \- Ability to understand treatment and give valid assent 5. \- Ability to comply with the protocol to get reliable study measurements 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 e.g. retinal disease, cataract, ptosis * 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 through known effects on retina, accommodation, or significant elevation of intraocular pressure 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

Locations (3)

Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department

Paris, France

Centre for Eye Research Ireland (CERI) - TU DUBLIN

Dublin, Ireland

Erasmus Medical Center

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Change in cycloplegic axial length

in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).

Time frame: from baseline to 24 months

Change in cycloplegic autorefraction

in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).

Time frame: from baseline to 24 months

Secondary Outcomes

Change in refraction progression centile

compared to expected change based on refraction centile positions at baseline (in each eye).

Time frame: from 12 months to 24 months visits.

Change in cycloplegic axial length

in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).

Time frame: from baseline to 12 months and 24 months

Change in cycloplegic autorefraction

compared to expected change based on refraction centile positions at baseline (in each eye).

Time frame: from baseline to 12 months and 24 months

Change in refraction

in D (Diopter) compared to that observed in control group participants of MOSAIC Study (myopia control trial conducted in Ireland from 2019 to 2023) (in each eye)

Time frame: during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study

Change in axial length

in mm (millimeter) compared to that observed in control group participants of the MOSAIC study (in each eye)

Data from ClinicalTrials.gov

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