Post Market Clinical Follow-up Study to Demonstrate the Efficacy, Safety, Acceptability and Quality of Life Implications of Essilor® Stellest® Spectacle Lenses in Slowing Myopia Progression in Children and Adolescents.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Essilor International
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Change in cycloplegic axial length
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
- •\- Monocular corrected VA of at least 0.2 LogMAR in both eyes
- •\- Age: 6 - 16 years old, inclusive at the time of inclusion
- •\- Ability to understand treatment and give valid assent
- •\- Ability to comply with the protocol to get reliable study measurements
Exclusion Criteria
- •\- Concomitant or previous therapies for myopia
- •\- 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
- •\- 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
- •\- Participation in another study which may influence vision or interfere with study assessments
- •\- Myopia onset before 5 years of age
- •\- Contact lens wearers
Outcomes
Primary Outcomes
Change in cycloplegic axial length
Time Frame: 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
Time Frame: from baseline to 24 months
in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).
Secondary Outcomes
- Change in cycloplegic axial length(from baseline to 12 months and 24 months)
- Change in cycloplegic autorefraction(from baseline to 12 months and 24 months)
- Change in refraction progression centile(from 12 months to 24 months visits.)
- Change in Paediatric Refractive Error Profile (PREP-2) score(from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®))
- Change in refraction(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in axial length(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in choroidal thickness(during the first and second year (separate comparisons for each year) of the MOSAIC study)
- Change in axial length vs atropine(during the first and second year (separate comparisons for each year) of the MOSAIC study.)