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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essilor® Stellest® spectacle lenses | Other | patients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (>12 hours daily) for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essilor® Stellest® spectacle lenses | Device | patients will be asked to wear Essilor® Stellest® spectacle lenses more than 12 hours per day for 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cycloplegic axial length | in mm (millimeter) compared to expected change based on axial length at baseline (in each eye). | from baseline to 24 months |
| Change in cycloplegic autorefraction | in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye). | from baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Change in cycloplegic axial length |
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Inclusion Criteria:
- Myopia as determined by cycloplegic autorefraction as follows:
- Monocular corrected VA of at least 0.2 LogMAR in both eyes
- Age: 6 - 16 years old, inclusive at the time of inclusion
- Ability to understand treatment and give valid assent
- Ability to comply with the protocol to get reliable study measurements
Exclusion Criteria:
- Concomitant or previous therapies for myopia
- Eye diseases/conditions:
- 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
- Participation in another study which may influence vision or interfere with study assessments
- Myopia onset before 5 years of age
- Contact lens wearers
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| Name | Affiliation | Role |
|---|---|---|
| Aude Couturier, Professor | Hôpital Fondation Adolphe de Rothschild - PARIS - FRANCE | Principal Investigator |
| Ian Flitcroft, Professor | Centre for Eye Research Ireland (CERI) - DUBLIN - IRELAND | Principal Investigator |
| Caroline Klaver, Professor | ERASMUS Medical Center - ROTTERDAM - NETHERLANDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department | Paris | 75019 | France | |||
| Centre for Eye Research Ireland (CERI) - TU DUBLIN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811039 | Background | 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. | |
| 35357402 | Background | 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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multicentre, European, prospective
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in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
| from baseline to 12 months and 24 months |
| 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 |
| Change in refraction | in D (Diopter) 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 |
| Change in axial length | in mm (millimeter) 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. |
| Change in choroidal thickness | in μm (micrometre) 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. |
| Change in refraction | in D (Diopter) 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. |
| Change in axial length vs atropine | in mm (millimeter) 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. |
| Change in choroidal thickness | in μm (micrometre) 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 |
| 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®) |
| Dublin |
| D07 H6K8 |
| Ireland |
| Erasmus Medical Center | Rotterdam | 3015 | Netherlands |
| 37040846 | Background | 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. |