NCT07845721尚未招募不适用
Twelve-Month Outcomes in Children Using MiSight® 1-Day Contact Lenses and Myopia Control Spectacle Lenses as Complementary Myopia Control Interventions.
CooperVision International Limited (CVIL)2 个研究点 分布在 2 个国家目标入组 58 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in axial length (AXL, mm) over 12 months
研究概览
简要总结
Effect of alternating contact lenses and spectacles for myopia control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are aged 11 to 17 years (inclusive);
- •Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study;
- •Are established soft contact lens wearers (including myopia control contact lens designs);
- •Have read and signed the study consent or assent form, as appropriate for their age;
- •Have a parent or legal guardian who has read and signed the Parent/Guardian Information Sheet (PIS) and Consent Form;
- •Are willing and able to follow study instructions and maintain the appointment schedule;
- •Are willing to wear the study contact lenses for 10 hours/day and 5 days per week as an ideal target while participating;
- •Require a spherical contact lens power correction between -0.50 and -6.00 D;
- •Have astigmatism not exceeding 2.00 DC in each eye by subjective refraction;
- •Have best-corrected visual acuity of 0.10 logMAR (approx. 20/25 Snellen) or better in each eye;
- •Have ocular health findings (biomicroscopy) that do not contraindicate contact lens wear;
- •Continue to demonstrate acceptable fit and handling with the study contact lenses.
排除标准
- •Are participating in any concurrent clinical or interventional study;
- •Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days;
- •Have used atropine concentrations above 0.01% for myopia control in the previous 30 days;
- •Are extended-wear contact lens users (i.e., sleep in their lenses);
- •Have best-corrected visual acuity worse than 0.10 logMAR in either eye;
- •Have any current or evolving ocular or systemic condition that could affect visual function, ocular growth, or contact lens wear;
- •Have any clinically significant corneal or conjunctival staining with sodium fluorescein, or other ocular findings contraindicating contact lens wear;
- •Are using systemic or topical medications known or expected to affect pupil size, tear production, accommodation, refractive state, or any study outcome variable;
- •Have a history of ocular surgery, keratoconus, or other forms of irregular cornea, or are aphakic;
- •Have diagnosed accommodative and/or binocular vision anomalies, including amblyopia, strabismus, or nystagmus;
- •Have known sensitivity or allergy to any of the diagnostic agents used in the study;
- •Have any systemic condition that, in the opinion of the investigator, may influence study outcomes or contraindicate soft contact lens wear, including pregnancy;
- •Are a child of an employee of either clinical site directly involved in the study.
研究组 & 干预措施
Test Group
Experimental
Participants will wear Test Spectacle Lens & Contact Lenses
干预措施: Test Spectacle Lens & Contact Lens (Device)
Control Group
Experimental
Participants will wear Control Spectacle Lens & Contact Lenses
干预措施: Control Spectacle Lens & Contact Lens (Device)
结局指标
主要结局
Change in axial length (AXL, mm) over 12 months
时间窗: Over 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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