NCT05089240已完成不适用
Data Collection of Objective Parameters and Subjective Feedback on Visually Fatigued Subjects and Evaluation of the Effect of Ophthalmic Lenses to Alleviate Visual Fatigue
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- The difference in number of participants with treatment-related adverse events between the two lenses
研究概览
简要总结
To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective report of visual fatigue
- •Non-presbyopes
- •Permanent wearers who wear glasses for at least 5 hours a day
- •Distance refractive error within the range of [+6.00 to -6.00]* (with cylinder in the negative form),
- •Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes,
- •Anisometropia ≤ 1.00 D in sperical equivalent,
- •Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance),
- •Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance)
- •Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance),
- •Study frame characteristics: Frame B size at least 22 mm
排除标准
- •Vulnerability of the subject,
- •Participation in another study which might have an influence on vision or interfere with study assessments,
- •Binocular vision problems,
- •Known ocular pathology (e.g., age-related macular degeneration, glaucoma...),
- •Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery...),
- •Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure...),
- •Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects...),
- •Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists...)
结局指标
主要结局
The difference in number of participants with treatment-related adverse events between the two lenses
时间窗: Immediately after the first and second wearing period (21 days each)
Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. Determined by subject's spontaneous reporting, the Investigator's non-leading questioning and his/her evaluation.
次要结局
未报告次要终点
研究者
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