Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

Myopia Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263946
• Other study ID #: WS10337
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Essilor International
• Contact: James Loughman, Professor
• Phone: + 353 1 220 5724
• Email: james.loughman[@]tudublin.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Essilor® Stellest® spectacle lenses
patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months.

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department	Paris
Ireland	Centre for Eye Research Ireland (CERI) - TU DUBLIN	Dublin
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Essilor International

Countries where clinical trial is conducted

France,  Ireland,  Netherlands, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cycloplegic axial length	compared to expected change based on axial length at baseline (in each eye).	from baseline to 24 months
Primary	Change in cycloplegic autorefraction	compared to expected change based on refraction centile positions at baseline (in each eye).	from baseline to 24 months
Secondary	Change in refraction progression centile	compared to expected change based on refraction centile positions at baseline (in each eye).	from 12 months to 24 months visits.
Secondary	Change in cycloplegic axial length	compared to expected change based on axial length at baseline (in each eye).	from baseline to 12 months and 24 months
Secondary	Change in cycloplegic autorefraction	compared to expected change based on refraction centile positions at baseline (in each eye).	from baseline to 12 months and 24 months
Secondary	Change in refraction	compared to that observed in control group participants of MOSAIC Study (myopia control trial conducted in Ireland from 2019 to 2023) (in each eye)	during the first and second year of the Myopia Outcome Study of Atropine In Children (MOSAIC) study
Secondary	Change in axial length	compared to that observed in control group participants of the MOSAIC study (in each eye)	during the first and second year (separate comparisons for each year) of the MOSAIC study.
Secondary	Change in choroidal thickness	compared to that observed in control group participants of the MOSAIC study (in each eye)	during the first and second year (separate comparisons for each year) of the MOSAIC study.
Secondary	Change in refraction	compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)	during the first and second year (separate comparisons for each year) of the MOSAIC study.
Secondary	Change in axial length vs atropine	compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)	during the first and second year (separate comparisons for each year) of the MOSAIC study.
Secondary	Change in choroidal thickness	compared to children treated with 0.01% atropine in group participants of the MOSAIC study (in each eye)	during the first and second year (separate comparisons for each year) of the MOSAIC study
Secondary	Change in Paediatric Refractive Error Profile (PREP-2) score	Change in Paediatric Refractive Error Profile (PREP-2) score	from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®)