A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Change from baseline in the Cylinder value through non cycloplegic autorefraction
研究概览
简要总结
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R&D Centre for scheduled follow-up sessions
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer participant
- •Informed consent of parent or guardian and assent of participant
- •Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.
- •Refractive error (manifest refraction):
- •With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
- •Astigmatism should be more than or equal to 1.50D
- •Least myopic meridian equal or less than -0.50D
- •Most myopic meridian equal or greater than -5.50D.
- •Anisometropia should be less than or equal to 1.00D
- •Best corrected visual acuity: Better than 0.2 logMAR in each eye
- •Willingness and ability to:
- •participate in trial for at least 12 months.
- •attend scheduled visits.
- •not to be involved in other myopia control treatments concurrently.
- •No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)
排除标准
- •History or presence of:
- •An ocular disease
- •Strabismus
- •Amblyopia
研究组 & 干预措施
Myopia Control Lens Prototype
Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements.
Device Details:
The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period.
干预措施: Lenslet-based myopia control spectacle lens (Device)
结局指标
主要结局
Change from baseline in the Cylinder value through non cycloplegic autorefraction
时间窗: 12 months
次要结局
- Change from baseline in the Keratometry value measured using a Keratometer(12 months)
- Change from baseline in the Axial Length value measured using a biometer(12 months)
- Quality of Life while wearing the study lenses measured through Questionnaire(Baseline, 6 and 12 months)