The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The lens which gives the best result in TES value
研究概览
简要总结
This study aimed to relate and compare the performance of 4 types of red-tinted contact lenses (CL) with the Total Error Score (TES) from the Farnsworth-Munsell 100 Hue test on colour deficient subjects. Only 6 subject with colour vision defect was tested in this study.
详细描述
Six congenital CVD subjects were recruited. After colour vision screening using Ishihara plate, the Farnsworth-Munsell 100 Hue test was carried out to determine the type and severity of colour vision deficiency. Four types of red-tinted CL (Type A, B, C and D) were used. The performance of each of these lenses was determined through the comparison of error scores in the Ishihara test before and after wearing tinted contact lens on only the non-dominant eye. Then, the transmittance of each tinted CL was determined using a spectrophotometer. All these lenses were fitted on the subjects in one day where the subjects were given a 30-minute break for each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the principal investigator knows the identity of each of the lenses.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18-40 years
- •color defect diagnosed with Ishihara Test
- •no contraindication in contact lens wear
排除标准
- •have ocular and systemic diseases
研究组 & 干预措施
TES and performance assessment with Type D Red Tint Lens
6 subjects will be inserted with the Type D red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.
干预措施: red tint contact lenses (Device)
TES and performance assessment with Type A Red Tint Lens
6 subjects will be inserted with the Type A red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.
干预措施: red tint contact lenses (Device)
TES and performance assessment with Type B Red Tint Lens
6 subjects will be inserted with the Type B red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.
干预措施: red tint contact lenses (Device)
TES and performance assessment with Type C Red Tint Lens
6 subjects will be inserted with the Type C red Tint Lenses. Only the non dominant eye will be inserted. The comparison is made before and after wearing the CL.
干预措施: red tint contact lenses (Device)
结局指标
主要结局
The lens which gives the best result in TES value
时间窗: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
The highest TES value scored showed higher performance in colour vision. TES is an automated, generated value that calculates the number of tiles placed incorrectly and scales the value for uniform analysis. Average TES scores range from thirty to forty in series tests; while scores exceeding seventy can point to a marker for color blindness. Lower scores are intended to point to significantly increased color vision accuracy, as the TES score is directly correlated to the number of tiles incorrectly identified
The lens which gives the best performance in ES value
时间窗: 30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed
The highest score achieved using Ishihara Test indicates the best red tint lens. The current passing score is 12 correct of 14 red/green test plates (not including the demonstration plate). Research has shown that scores below twelve indicate color vision deficiency, and twelve or more correct indicate normal color vision, with 97% sensitivity and 100% specificity
次要结局
未报告次要终点