Myopia
Conditions
Brief 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.
Detailed description
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.
Interventions
patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.
Sponsors
Essilor International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multicentre, European, prospective
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cycloplegic axial length | from baseline to 24 months | in mm (millimeter) compared to expected change based on axial length at baseline (in each eye). |
| Change in cycloplegic autorefraction | from baseline to 24 months | in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in refraction progression centile | from 12 months to 24 months visits. | compared to expected change based on refraction centile positions at baseline (in each eye). |
| Change in cycloplegic axial length | from baseline to 12 months and 24 months | in mm (millimeter) compared to expected change based on axial length at baseline (in each eye). |
| Change in cycloplegic autorefraction | from baseline to 12 months and 24 months | compared to expected change based on refraction centile positions at baseline (in each eye). |
| Change in refraction | during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study | 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) |
| Change in axial length | during the first and second year (separate comparisons for each year) of the MOSAIC study. | in mm (millimeter) compared to that observed in control group participants of the MOSAIC study (in each eye) |
| Change in choroidal thickness | during the first and second year (separate comparisons for each year) of the MOSAIC study. | in μm (micrometre) compared to that observed in control group participants of the MOSAIC study (in each eye) |
| Change in axial length vs atropine | during the first and second year (separate comparisons for each year) of the MOSAIC study. | in mm (millimeter) compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye) |
| Change in Paediatric Refractive Error Profile (PREP-2) score | from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®) | Change in Paediatric Refractive Error Profile (PREP-2) score |
Countries
France, Ireland, Netherlands
Contacts
PRINCIPAL_INVESTIGATORAude Couturier, Professor
Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE
PRINCIPAL_INVESTIGATORIan Flitcroft, Professor
Centre for Eye Research Ireland (CERI) - DUBLIN - IRELAND
PRINCIPAL_INVESTIGATORCaroline Klaver, Professor
ERASMUS Medical Center - ROTTERDAM - NETHERLANDS
Outcome results
None listed