Crossover Comparison of Two Novel Stenfilcon A Contact Lens Designs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Computer vision syndrome questionnaire (CVS-Q)
研究概览
简要总结
The proposed study will address this gap by comparing the efficacy of two novel stenfilcon A contact lens designs in alleviating accommodative burden associated with digital device usage.
The primary outcomes are measured with the following:
- Computer vision syndrome questionnaire
- Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm.
- Binocular range of clear vision
- Subjective assessment of accommodation
- Objective assessment of accommodation Subjects will be randomly assigned to wear one contact lens design for 5 days. Then crossed over tot he opposing design after a three day washout period, and again asked to wear the lens for 5 days.
详细描述
Digital device use is associated with symptoms known as Computer Vision Syndrome (CVS), which may include eye strain, dryness, blurred vision, and headaches. Contact lens wearers may experience increased symptoms during prolonged near-focus activities. New contact lens designs have been developed to help reduce accommodative stress during digital device use; however, clinical evidence comparing their performance remains limited.
This randomized, double-masked, crossover study will compare two daily disposable stenfilcon A contact lenses. Each participant will wear both lens designs for five days each, separated by a three-day washout. Primary outcomes include subjective symptoms, visual acuity, range of clear vision, subjective accommodative performance, and objective accommodative response. The study is designed to provide evidence regarding the relative performance of the two lens designs in reducing visual discomfort and accommodative burden during digital device use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of >6 on CVS-Q
- •Male or female
- •Age >18 years to 35 years of age
- •Experienced, well-adapted contact lens wearers
- •Spherical equivalent refractive error between ±6.00DS with astigmatism < -0.75D
- •Normal stereopsis and binocular status
排除标准
- •Monovision
- •History of refractive surgery
- •Binocular vision abnormalities
- •Current ocular or systemic disease that may affect the eye
- •Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
结局指标
主要结局
Computer vision syndrome questionnaire (CVS-Q)
时间窗: Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks)
Computer vision syndrome questionnaire (CVS-Q) is a reliable and valid tool for measuring visual symptoms related to computer use in the workplace. It asks subjects to rate the frequency (never, occasionally, often) and intensity (moderate, intense) of 16 visual symptoms.
次要结局
- Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm(Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks))
- Subjective assessment of accommodation(Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks))
- Objective assessment of accommodation(Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks))
研究者
Yueren Wang, OD
Assistant Professor
Southern College of Optometry