Using Essilor Stellest lenses to slow myopia progression in children

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.

This study is testing if special Essilor Stellest lenses can help slow down worsening eyesight in kids and teens aged 6 to 16.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 6 Years to 16 Years
• Sex: All
• Sponsor: Essilor International (Industry-sponsored)
• Locations: 3 sites (Paris and 2 other locations)
• Trial ID: NCT06263946 on ClinicalTrials.gov

What this trial studies

This multicentre European study aims to evaluate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing the progression of myopia in children and adolescents aged 6 to 16. Participants will wear the lenses full-time for 24 months, with primary endpoints focusing on changes in axial length and cycloplegic autorefraction. The study will also assess the lenses' acceptability, safety, and their impact on choroidal thickness and quality of life. A total of 150 participants will be recruited across sites in Ireland, France, and the Netherlands.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents aged 6 to 16 years with myopia and specific refractive criteria.

Not a fit: Patients with previous myopia treatments or certain eye diseases that could affect refractive development may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective method for controlling myopia progression in children, potentially reducing the risk of associated complications later in life.

How similar studies have performed: Other studies have shown promising results with similar myopia control approaches, suggesting potential for success in this study.

Eligibility criteria

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

Where this trial is running

Paris and 2 other locations

• Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department — Paris, France (Recruiting)
• Centre for Eye Research Ireland (CERI) - TU DUBLIN — Dublin, Ireland (Active_not_recruiting)
• Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Sophie Bonnin, Doctor — Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE
• Study coordinator: James Loughman, Professor

Conditions Myopia