NCT06475053进行中（未招募）不适用
Visual Performance of Center Distance Daily Disposable Multifocal Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight.
研究概览
简要总结
The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the examiner tasked with obtaining study outcome data will be masked to the design or brand of lenses. An unmasked examiner will be available to address any issues of lens wear or other adverse events.
入排标准
- 年龄范围
- 9 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must satisfy the following conditions for inclusion in the trial:
- •Be between 9 and 30 years of age
- •Sign written Informed Consent/Assent.
- •Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D
- •20/20 vision in each eye
- •Existing contact lens wearer
- •An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available)
- •No known ocular disease - anterior or posterior (posterior determined by history/chart)
- •Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study.
- •On examination, have ocular findings considered to be within normal limits.
- •Be willing and able to follow instructions and attend the schedule of follow-up visits.
排除标准
- •Any of the following will exclude a participant from this trial:
- •Current hard lens wearers
- •Using eye medication contraindicating lens wear such as daily use of artificial tears.
- •Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- •History of corneal refractive surgery
- •Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial.
- •Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- •Allergy or sensitivity to any product used in this trial.
- •Pre-existing ocular condition that would contraindicate lens wear.
- •Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses.
- •Lazy eye (Strabismus or amblyopia)
- •Pupil size < 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )
结局指标
主要结局
Comparison of visual performance (high and low contrast acuity) between VTI NaturalVue Enhanced Multifocal and CooperVision MiSight.
时间窗: 2 months
log MAR vision scale
次要结局
未报告次要终点
研究者
研究点 (2)
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