Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Macular Pigment Optical Density at 15 months
研究概览
简要总结
The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •The subject is an adapted soft contact lens wearer
- •The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
- •The subject must have a refractive astigmatism in each eye of -0.75D or less
- •The subject must have a best corrected visual acuity of 6/9 or better in each eye.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- •The subject must read and sign the statement of informed consent
- •The subject must be at least 18 years of age
排除标准
- •Systemic or ocular allergies which might interfere with contact lens wear
- •Systemic disease which might interfere with contact lens wear
- •Ocular disease which might interfere with contact lens wear
- •Grade 3 or 4 Slit Lamp Findings
- •Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
- •On changing stable medication or taking any medication known to affect tear film
- •Active ocular surface pathology
- •Use ocular medication
- •Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
- •Significant ocular tissue anomaly
- •Presence of two or more corneal scars in either eye
- •Pregnancy or lactation, or intends to become pregnant during the time period of the study
- •Any medical condition that may be prejudicial to the study
- •Infectious diseases (e.g. Hepatitis, tuberculosis)
- •Contagious immunosuppressive diseases (e.g. HIV)
研究组 & 干预措施
nelfilcon A OD / narafilcon A OS
Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS).
干预措施: narafilcon A contact lens (Device)
nelfilcon A OD / narafilcon A OS
Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS).
干预措施: nelfilcon A soft contact lenses (Device)
narafilcon A OD / nelfilcon A OS
Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS).
干预措施: narafilcon A contact lens (Device)
narafilcon A OD / nelfilcon A OS
Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS).
干预措施: nelfilcon A soft contact lenses (Device)
结局指标
主要结局
Macular Pigment Optical Density at 15 months
时间窗: baseline to 15 months
Macular Pigment Optical Density at 9 months
时间窗: baseline to 9 months
次要结局
- Macular Pigment Optical Density at 3 months(baseline to 3 months)
- Macular Pigment Optical Density at 12 months(baseline to 12 months)
- Macular Pigment Optical Density at 6 months(baseline to 6 months)