Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Device: Essilor® Stellest® spectacle lenses

• Registration Number: NCT06263946
• Lead Sponsor: Essilor International

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.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-16
• Study Start: 2024-03-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2027-02-28
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Essilor® Stellest® spectacle lenses	Essilor® Stellest® spectacle lenses	patients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (\>12 hours daily) for 24 months

Primary Outcome Measures

Name	Time	Method
Change in cycloplegic axial length	from baseline to 24 months	compared to expected change based on axial length at baseline (in each eye).
Change in cycloplegic autorefraction	from baseline to 24 months	compared to expected change based on refraction centile positions at baseline (in each eye).

Secondary Outcome Measures

Name	Time	Method
Change in axial length	during the first and second year (separate comparisons for each year) of the MOSAIC study.	compared to that observed in control group participants of the MOSAIC study (in each eye)
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 choroidal thickness	during the first and second year (separate comparisons for each year) of the MOSAIC study	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
Change in cycloplegic axial length	from baseline to 12 months and 24 months	compared to expected change based on axial length at baseline (in each eye).
Change in axial length vs atropine	during the first and second year (separate comparisons for each year) of the MOSAIC study.	compared to children treated with 0.01% atropine in group participants of the MOSAIC study (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 (separate comparisons for each year) of the MOSAIC study.	compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)

Trial Locations

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