Study on the Effect of Filters on Discomfort Glare on Healthy Adults

Официальное название

Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort

Обзор

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.

Вмешательства

• Другое Filter comparison
  Three filters will be compared on light discomfort thresholds using the Lumiz 100™ device

Первичные конечные точки

• Light discomfort thresholds [Срок оценки: 2 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Institut des Sciences de la Vision — Saint-Etienne

Идентификаторы

NCT: NCT06701981 · WS10399 · 2024-A00934-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗