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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Change in cycloplegic axial length
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
- •- 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
排除标准
- •- Concomitant or previous therapies for myopia
- •- 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
- •- 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
研究组 & 干预措施
Essilor® Stellest® spectacle lenses
patients will be asked to wear Essilor® Stellest® spectacle lenses for a full time wear (>12 hours daily) for 24 months
干预措施: Essilor® Stellest® spectacle lenses (Device)
结局指标
主要结局
Change in cycloplegic axial length
时间窗: from baseline to 24 months
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
Change in cycloplegic autorefraction
时间窗: from baseline to 24 months
in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).
Change in cycloplegic axial length
时间窗: from baseline to 24 months
in mm (millimeter) compared to expected change based on axial length at baseline (in each eye).
Change in cycloplegic autorefraction
时间窗: from baseline to 24 months
in D (Diopter) compared to expected change based on refraction centile positions at baseline (in each eye).
次要结局
- Change in refraction progression centile(from 12 months to 24 months visits.)
- Change in cycloplegic axial length(from baseline to 12 months and 24 months)
- Change in refraction(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in axial length(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in choroidal thickness(during the first and second year (separate comparisons for each year) of the MOSAIC study)
- Change in axial length vs atropine(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in Paediatric Refractive Error Profile (PREP-2) score(from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®))
- Change in cycloplegic axial length(from baseline to 12 months and 24 months)
- Change in cycloplegic autorefraction(from baseline to 12 months and 24 months)
- Change in refraction progression centile(from 12 months to 24 months visits.)
- Change in Paediatric Refractive Error Profile (PREP-2) score(from baseline (pre- Essilor® Stellest®) to 12 and 24 months (post- Essilor® Stellest®))
- Change in refraction(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in axial length(during the first and second year (separate comparisons for each year) of the MOSAIC study.)
- Change in choroidal thickness(during the first and second year (separate comparisons for each year) of the MOSAIC study)
- Change in axial length vs atropine(during the first and second year (separate comparisons for each year) of the MOSAIC study.)