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Essilor® Stellest® Lenses Multicentre European Study (SLOMES) - Trial NCT06263946

Access comprehensive clinical trial information for NCT06263946 through Pure Global AI's free database. This phase not specified trial is sponsored by Essilor International and is currently Not yet recruiting. The study focuses on Myopia. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.govNCT06263946
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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.

Study Focus

Myopia

Essilor® Stellest® spectacle lenses

Interventional

device

Sponsor & Location

Essilor International

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 30, 2026

150 participants

Primary Outcome

Change in cycloplegic axial length,Change in cycloplegic autorefraction

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.

ICD-10 Classifications

Myopia
Degenerative myopia
Amblyopia ex anopsia
Ocular myiasis
Myiasis

Data Source

ClinicalTrials.gov

NCT06263946

Device Trial