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

Not Applicable

Not yet recruiting

• Conditions: Glare

• Registration Number: NCT06701981
• Lead Sponsor: Essilor International

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-02
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Light discomfort thresholds	2 hours	Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)

Trial Locations

Locations (1)

Institut des Sciences de la Vision; 🇫🇷 Saint Etienne, France