Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2025-12-17 @ 7:47 AM
Study NCT ID:
NCT06263946
Status:
None
Last Update Posted:
2025-12-01 00:00:00
First Post:
2024-01-29 00:00:00
Brief Title:
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)
Sponsor:
Essilor International
Organization:
Essilor International
Study Overview
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.
Status:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLOMES
Brief Summary:
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.
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.
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None