Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (3)

More Essilor International trials in France

Other trials for the same condition