Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses
研究概览
简要总结
The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light sensitivity) following a concussion, with the goal of facilitating the return to work or school.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •diagnosed mild traumatic brain injury (concussion)
- •age 18 or older
- •Within 24 months of initial injury
- •experiencing symptoms of photophobia (light sensitivity), increased photophobia since the injury, or no symptoms of photophobia
排除标准
- •moderate or severe concussion
- •active infection or inflammation that contradicts the use of soft contact lenses
- •subjects unable to safely perform insertion and removal of the contact lenses
研究组 & 干预措施
Participants with concussion and light sensitivity fit with broad band (clear) contact lens
UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses.
干预措施: broad band (clear) contact lenses (Device)
Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens
UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses.
干预措施: Narrow band (tinted) contact lenses (Device)
结局指标
主要结局
Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses
时间窗: Baseline, 1 week
Improvement in the Utah Photophobia Symptom Impact Scale version 2 (UPSIS-2) on a scale of 15-60. Anything over 26 is considered significant.
次要结局
未报告次要终点
研究者
Candice Turner
Associate Professor
University of Alabama at Birmingham