NCT06263946

Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia

Interventions

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

Timeline

• Start date: 2024-03-22
• Primary completion: 2027-04-23
• Completion: 2027-04-30
• First posted: 2024-02-16
• Last updated: 2025-12-01

Locations

3 sites across 3 countries: France, Ireland, Netherlands