Study on the Effect of Filters on Discomfort Glare on Healthy Adults (PREVIS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glare
• Intervention / Treatment: Other: Filter comparison

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascale Lacan, PhD; Phone Number: +33155964816; Email: lacanp@essilor.fr

Study Locations

• France
  • Saint Etienne, France, 42100
    • Institut des Sciences de la Vision
    • Contact: Aurore Munier, Doctor of Optometry; Phone Number: + 33 (0) 4 77 95 31 70; Email: a.munier@isvision.fr
    • Contact: Aurore Munier, Doctor of optometry
    • Contact: Sophie Comte, Doctor of optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glare discomfort measures with filters	Other: Filter comparison; Three filters will be compared on light discomfort thresholds using the Lumiz 100™ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Light discomfort thresholds	Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)	2 hours

Collaborators and Investigators

• Sponsor: Essilor International
• Investigators: Study Director: Pascale Lacan, Phd, Essilor International

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: glare; filter
• Other Study ID Numbers: WS10399; 2024-A00934-43 (Registry Identifier: ANSM RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No