NCT05285527进行中（未招募）不适用
MiSight 1 Day Safety Post-Approval Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 100
- 主要终点
- Incidence of Microbial Keratitis (MK)
研究概览
简要总结
The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
详细描述
This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.
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
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 8 and 12 years of age inclusive at the time of enrollment.
- •Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
- •Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
- •Free of ocular disease or abnormalities (including any corneal scar)
- •The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB.
- •Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
- •Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
- •Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
排除标准
- •Acute and subacute inflammation or infection of the anterior chamber of the eye.
- •Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
- •Severe insufficiency of lacrimal secretion (dry eyes).
- •Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
- •Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
- •Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
- •Any active corneal infection (bacterial, fungal, or viral).
- •If eyes are red or irritated.
- •The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
- •In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.
研究组 & 干预措施
MiSight 1 Day
Experimental
MiSight 1 Day
干预措施: MiSight 1 Day (Device)
结局指标
主要结局
Incidence of Microbial Keratitis (MK)
时间窗: 3 years
Incidence of Microbial Keratitis (MK) ≥ 1 mm
次要结局
- Incidence of peripheral infiltrative keratitis/non-infectious ulcers(3 years)
- Incidence of non-infectious infiltrative keratitis(3 years)
- Incidence of loss of best-corrected visual acuity(3 years)
研究者
研究点 (100)
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