Immediate and Extended Wear Impact of Color Correcting Lenses on Color Vision Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Color Matching
研究概览
简要总结
To demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.
详细描述
The long term objective of this study is to extend upon research demonstrating improvements in color vision deficiencies (CVDs) while wearing color-correcting lenses (CCLs) and after wearing CCLs. Recordings of brainwaves and eye-waves will be made to assess the retina, optic nerve and brain in order to localize where adaptive changes in the visual system are occurring in response to wearing CCLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •no reported history of eye, systemic or ocular disease
- •VA of 20/30 in each eye
- •hereditary color vision deficient (CVDs) verified by failing scores on the red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)
- •color vision normal (CVNs) verified by passing red-green anomaloscope (outside system normal range) and Ishihara testing (3 or more errors on 14 testable plates)
排除标准
- •reported use of sleep-inducing or wakefulness drugs
研究组 & 干预措施
Color Vision Deficient with Color Correcting Lenses
10 subjects confirmed to have hereditary color vision deficiency randomly assigned to experimental group 1 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.
干预措施: Experimental Group 1: Color Correcting Lenses (Device)
Color Vision Deficient with Placebo Lenses
10 subjects confirmed to have hereditary color vision deficiency randomly assigned to Placebo Group 1 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.
干预措施: Placebo Group 1: Placebo Lenses (Device)
Crossover: Placebo to Experimental
Placebo Group 1 crosses over to become Experimental Group 2 which includes baseline testing with and without color correcting lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without color correcting lenses.
干预措施: Placebo Group 1 Crosses over to become Experimental Group 2: Color Correcting Lenses (Device)
Crossover: Experimental to Placebo
Experimental Group 1 crosses over to become Placebo Group 2 which includes baseline testing with and without placebo lenses, followed by 7 days of wear, minimum 3 hours/day, followed by retesting with and without placebo lenses.
干预措施: Experimental Group 1 Crosses over to become Placebo Group 2: Placebo Lenses (Device)
Control Group: Subjects with Normal Color Vision
Fifteen subjects confirmed to have normal color vision will be tested in a single session to determine whether color correcting lenses affect color vision in color vision normal subjects and to provided normative data for several unique measures of color vision performance
干预措施: Color Correcting Lenses in Subjects with Normal Color Vision (Device)
结局指标
主要结局
Color Matching
时间窗: 2 Weeks
Cone specific color matching provides the contrast seen by the normal cone type which matches the contrast seen by the defective cone type in units of % Weber contrast. Values will be converted to Z-scores to compare to outcomes with other units.
Visual Electrodiagnostic Testing
时间窗: 2 Weeks
Cone specific visual brainwaves (VEPs) and flash and pattern eye waves (ERGs) will be quantified in terms of amplitude in microvolts and latency in msec. Values will be converted to Z-scores to compare to outcomes with other units.
Color Identification Test
时间窗: 2 Weeks
Cockpit color identification test measure reaction time in seconds and error rate to identify colored targets on a computer display. Values will be converted to Z-scores to compare to outcomes with other units.
Cone Contrast Test
时间窗: 2 WeekS
Cone Contrast Sensitivity (CS) Test (CCT, Innova Systems, Inc.): red, green \& blue cone CS using 100-point scale based on log changes in CS. Values will be converted to Z-scores to compare to outcomes with other units.
Cone Contrast Naming Test
时间窗: 2 Weeks
Red, green \& blue cone CS and color naming accuracy each based on 100-point scale. Values will be converted to Z-scores to compare to outcomes with other units.
Letter Chart Testing
时间窗: 2 Weeks
Letter chart cone specific VA, small letter CS, and large letter CS scored as number of letters correct with VA expressed as log MAR \& CS as log CS. Values will be converted to Z-scores to compare to outcomes with other units.
次要结局
未报告次要终点
研究者
JEFFREY CARL RABIN
Professor
University of the Incarnate Word