EsSiLOr Stellest Lenses Multicentre European Study

• Conditions: Myopia; nearsightedness; 10047518

• Registration Number: NL-OMON56621
• Lead Sponsor: Essilor International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

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

Exclusion Criteria

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
- 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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in axial length and cycloplegic autorefraction from baseline to 24<br /><br>months compared to expected change based on axial length and refraction centile<br /><br>positions at baseline.</p><br>