NCT07218731进行中（未招募）不适用
Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasse
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
- 30
- 试验地点
- 2
- 主要终点
- Preference Survey
研究概览
简要总结
The purpose of the study is to assess participant experience when wearing multifocal contact lenses compared to spherical contact lenses with reading glasses.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 40 years of age.
- •Ability to give informed consent.
- •Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
- •Require an add power of +0.75 D or greater when tested at 40cm.
- •Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
排除标准
- •Current or active inflammation or infection as determined by the Investigator.
- •Current eye disease, infection or inflammation that affects the surface of the eye such as but not limited to moderate or greater blepharitis and ocular allergy.
- •History of refractive surgery.
- •Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein.
- •Is pregnant or lactating or planning a pregnancy during enrollment of the study.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
- •Have been diagnosed with dry eye previously
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
研究组 & 干预措施
Multifocal contact lenses
Active Comparator
multifocal contact lenses
干预措施: Multifocal contact lenses (Device)
Spherical contact lenses with reading glasses
Active Comparator
spherical contact lenses used with reading glasses
干预措施: Spherical contact lenses (Device)
结局指标
主要结局
Preference Survey
时间窗: 8 weeks
Percentage of participants who prefer the multifocal lenses compared to spherical lenses with reading glasses.
次要结局
未报告次要终点
研究者
Jennifer Fogt
Principal Investigator
Ohio State University
研究点 (2)
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