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ACTIVE NOT RECRUITING
NCT06263946
NA

Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Sponsor: Essilor International

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

6 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-03-22

Completion Date

2027-04-30

Last Updated

2025-12-01

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Essilor® Stellest® spectacle lenses

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

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