Informations générales (source: ClinicalTrials.gov)
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. (SLOMES)
Interventional
N/A
Essilor International (Voir sur ClinicalTrials)
mars 2024
mars 2027
22 novembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Ramin TADAYONI | 11/02/2025 15:49:05 | Contacter | ||
Critères
Tous
Inclusion Criteria:
1.
- Myopia as determined by cycloplegic autorefraction as follows:
- Each meridian SER of plano to - 8;00 D in each eye
- Astigmatism < 2.50 D
- Anisometropia ≤ 1.50 D
2.
- Monocular corrected VA of at least 0.2 LogMAR in both eyes
3.
- Age: 6 - 16 years old, inclusive at the time of inclusion
4.
- Ability to understand treatment and give valid assent
5.
- Ability to comply with the protocol to get reliable study measurements
1.
- Myopia as determined by cycloplegic autorefraction as follows:
- Each meridian SER of plano to - 8;00 D in each eye
- Astigmatism < 2.50 D
- Anisometropia ≤ 1.50 D
2.
- Monocular corrected VA of at least 0.2 LogMAR in both eyes
3.
- Age: 6 - 16 years old, inclusive at the time of inclusion
4.
- Ability to understand treatment and give valid assent
5.
- Ability to comply with the protocol to get reliable study measurements
1.
- Concomitant or previous therapies for myopia
2.
- Eye diseases/conditions:
- Strabismus by cover test at near or distance
- Any ocular disease that would influence refractive development e.g. retinal
disease, cataract, ptosis
- Any systemic or neurodevelopmental conditions that may influence refractive
development
3.
- Use of ocular or systemic medication which may affect myopia progression or
visual acuity through known effects on retina, accommodation, or significant
elevation of intraocular pressure
4.
- Participation in another study which may influence vision or interfere with
study assessments
5.
- Myopia onset before 5 years of age
6.
- Contact lens wearers