Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Essilor

Status: Enrolling

Conditions: Myopia

Treatments: Device: Essilor® Stellest® spectacle lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06263946

WS10337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Essilor® Stellest® spectacle lenses

Other group

Description:

patients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (\>12 hours daily) for 24 months

Treatment:

Device: Essilor® Stellest® spectacle lenses