NCT02053688已完成不适用
Evaluation Study on Corneal Lens for Vision Correction
FORSIGHT Vision312 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with good corneal health
- •Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
- •Best corrected visual acuity of 20/20 or better in the study eye/s
排除标准
- •Any other anterior segment abnormality.
- •No previous corneal procedures, including Laser Vision Correction.
- •Any abnormalities associated with the eye lids.
- •Clinically significant inflammation or infection within six (6) months prior to study.
- •Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
- •Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
- •Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
- •Specifically known intolerance or hypersensitivity to contact lenses.
- •Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
结局指标
主要结局
Visual Acuity
时间窗: 30 mins
次要结局
未报告次要终点
研究者
研究点 (12)
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