NCT06701981尚未招募不适用
Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Light discomfort thresholds
研究概览
简要总结
The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Each measurement will be repeated three times. The study requires a single visit of 2 hours for each participant. Glare protection will be quantified by comparing discomfort thresholds across the no-filter condition and the two studied filters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A willing person, fluent in French, inclined to follow protocol, capable of reading and understanding the information form, and able to give their free and informed consent.
- •Beneficiary of the French Social Security system
- •Aged 18 to 65 years
- •No or moderate ocular correction (Spherical prescription for distance vision: in the range [-8.00 to +6.00 D]* (negative cylinder) for each eye; Cylindrical prescription for distance vision: in the range [0 to -4.00 D] for each eye; Anisometropia ≤ 2.00 D on the equivalent sphere)
- •Correct vision with prescription glasses (Corrected visual acuity +0.10 logMAR or better (distance vision / high contrast / photopic luminance)
- •Regular user of sunglasses at least in bright light conditions
排除标准
- •Age < 18 years (i.e., no minors in accordance with Article L1121-7 of the Public Health Code of "Code de Santé Publique")
- •Pregnant, parturient, or breastfeeding women (Article L1121-5 of the Public Health Code of "Code de Santé Publique")
- •Persons deprived of liberty by judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, and persons admitted to a health or social institution for purposes other than research
- •Adults incapable or unable to express their consent (Article L1121-8 of the Public Health Code of "Code de Santé Publique")
- •Participant in the exclusion period of another biomedical research study
- •Participant who cannot be contacted in case of emergency
- •All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)
- •Employees at the Institut des Sciences de la Vision or EssilorLuxottica
- •Ocular pathology that may affect vision (e.g., glaucoma involving visual field loss, maculopathy involving visual acuity loss, or retinitis pigmentosa causing significant discomfort in poorly or overly lit environments)
- •Neurological deficit, including a history of epileptic pathology or regular or severe migraines
- •Ocular surgery affecting vision (e.g., refractive surgery, cataract surgery, or iridectomy)
- •Ocular or head trauma
结局指标
主要结局
Light discomfort thresholds
时间窗: 2 hours
Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)
次要结局
未报告次要终点
研究者
研究点 (2)
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