Clinical trial NCT06701981: Study on the Effect of Filters on Discomfort Glare on Healthy Adults
Official title: Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glare
Keywords: glare
filter
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Light discomfort thresholds
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Institut des Sciences de la Vision
Study officials:
affiliation: Essilor International
name: Pascale Lacan, Phd
role: STUDY_DIRECTOR
References: