Clinical trial NCT06263946: Essilor® Stellest® Lenses Multicentre European Study (SLOMES)
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2024-02-16
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multicentre, European, prospective
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in cycloplegic axial length
timeFrame: from baseline to 24 months
measure: Change in cycloplegic autorefraction
timeFrame: from baseline to 24 months
Secondary outcomes:
measure: Change in refraction progression centile
timeFrame: from 12 months to 24 months visits.
measure: Change in cycloplegic axial length
timeFrame: from baseline to 12 months and 24 months
measure: Change in cycloplegic autorefraction
timeFrame: from baseline to 12 months and 24 months
measure: Change in refraction
timeFrame: during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study
measure: Change in axial length
timeFrame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
measure: Change in choroidal thickness
timeFrame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
measure: Change in refraction
timeFrame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
measure: Change in axial length vs atropine
timeFrame: during the first and second year (separate comparisons for each year) of the MOSAIC study.
measure: Change in choroidal thickness
timeFrame: during the first and second year (separate comparisons for each year) of the MOSAIC study
measure: Change in Paediatric Refractive Error Profile (PREP-2) score
timeFrame: from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department
city: Dublin
country: Ireland
facility: Centre for Eye Research Ireland (CERI) - TU DUBLIN
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE
name: Sophie Bonnin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Eye Research Ireland (CERI) - DUBLIN - IRELAND
name: Ian Flitcroft, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: ERASMUS Medical Center - ROTTERDAM - NETHERLANDS
name: Caroline Klaver, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.
citation: Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
citation: Li X, Huang Y, Yin Z, Liu C, Zhang S, Yang A, Drobe B, Chen H, Bao J. Myopia Control Efficacy of Spectacle Lenses With Aspherical Lenslets: Results of a 3-Year Follow-Up Study. Am J Ophthalmol. 2023 Sep;253:160-168. doi: 10.1016/j.ajo.2023.03.030. Epub 2023 Apr 10.