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NCT Number: NCT06701981

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut des Sciences de la Vision

Saint-Etienne, France, 42100

Location contact

Aurore Munier, Doctor of Optometry

CONTACT

[email protected]

+ 33 (0) 4 77 95 31 70

Aurore Munier, Doctor of optometry

CONTACT

Sophie Comte, Doctor of optometry

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filter comparison

Other

Three filters will be compared on light discomfort thresholds using the Lumiz 100™ device

Primary outcomes

  1. Light discomfort thresholds

    Time frame: 2 hours

    Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)

Study contacts

Contact information is provided by the study sponsor or research team.

Pascale Lacan, PhD

CONTACT

[email protected]

+33155964816

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

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

Acronym: PREVIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.