NCT02643095已完成不适用
Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses
Jennifer Fogt0 个研究点目标入组 22 人开始时间: 2016年1月26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
- 22
- 主要终点
- The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
研究概览
简要总结
This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- •Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.
- •The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- •Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.
- •Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).
排除标准
- •Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
- •Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- •Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
- •Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
- •Subjects who are participating in any other clinical trial (FDA or other)
结局指标
主要结局
The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
时间窗: 1 month after lens is dispensed
Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses
次要结局
未报告次要终点
研究者
Jennifer Fogt
Assistant Professor
Ohio State University
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