Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs

NCT07844408 · tracked via the Priya Life Science France tracker

Sponsor

Essilor International

Phase

Not applicable

Started

2026-10

Last updated

2026-09-28

Condition(s) studied

MyopiaDry Eye Disease (DED)

Investigational drug(s) / intervention(s)

Eye ExamsOcular Biometry and AberrometryWearing a SmartwatchWearing Visual CorrectionEye-Blinking TestsRetinal ExaminationAssessment of Signs and Symptoms of Dry EyeAssessment of Digital Eye Strain SymptomsContrast Sensitivity AssessmentDigital Eye Strain Task

Eye Exams: Participants undergo several visual examinations (visual function, visual refraction, visual acuity).

Ocular Biometry and Aberrometry: Participants complete ocular aberrometric and biometric measurements.

Wearing a Smartwatch: Participants wear an smartwatch to measure their physiological activity.

Wearing Visual Correction: Participants are equipped with appropriate vision correction through spectacle lenses.

Eye-Blinking Tests: Before and after a digital eye strain task, participants perform eye-blinking tests on a screen.

Retinal Examination: Before and after a digital eye strain task, participants undergo a retinal examination.

Assessment of Signs and Symptoms of Dry Eye: Before and after a digital eye strain task, participants' signs and symptoms of dry eye are assessed.

Assessment of Digital Eye Strain Symptoms: Before and after a digital eye strain task, participants assess their symptoms of digital eye strain.

Contrast Sensitivity Assessment: Before and after a digital eye strain task, participants perform contrast sensitivity tests.

Digital Eye Strain Task: Participants perform a 30-minute task designed to induce digital eye strain. During this task, eye movements, including blinking behavior, saccade and fixation behavior, are recorded by an eye tracker.

Study summary

The goal of this observational study is to investigate the effects of eye fatigue induced by screen task on dry eye disease (DED) signs and symptoms, visual performance, and visual behavior in young adults with and without DED and with normal vision and myopia. The main questions it aims to answer are:

* Does a screen task that induces eye fatigue affect dry eye signs and symptoms, visual quality, and visual behavior?
* Are the effects of this screen task different in individuals with and without DED, and are they associated with myopia?

Researchers will compare participants with and without DED to determine whether they respond differently to a screen task designed to induce eye fatigue. They will also explore potential relationships between DED and myopia.

Participants will:

* Attend two study visits.
* Complete eligibility screening and realize visual and eye assessments.
* Be classified as having or not having DED based on a questionnaire and clinical eye examinations.
* Perform a screen task designed to induce eye fatigue.
* Perform measurements before and after a screen task, including assessments of DED signs and symptoms, blinking behavior, eye movements, visual performance, and physiological responses with a smartwatch.

Eligibility

Sex

ALL

Min age

18 Years

Max age

35 Years

Healthy volunteers

Accepted

Inclusion Criteria: * A willing participant who speaks French fluently, is willing to follow the protocol, is able to read and understand the informed consent form, and can give their free and informed consent; * Age between 18 and 35 years * Daily screen use of more than 4 hours * Monocular and binocular distance and near visual acuity of 0.1 logMAR or better (equivalent to 20/25 Snellen or 8/10) with best optical correction * Emmetropic groups: * Spherical equivalent (SE): -0.50 D \< SE ≤ +0.50 D * Regular astigmatism (cylinder) 0.75 D (absolute value) * Anisometropia 1.00 D * Myopic groups: * Spherical equivalent (SE): -5.00 D ≤ SE ≤ -0.50 D * Regular astigmatism (cylinder) 0.75 D (absolute value) * Anisometropia 1.50 D * Groups with signs and symptoms of DED: * OSDI-6 questionnaire score ≥ 4 * NIBUT \<10 seconds * Groups without signs and symptoms of DED: * OSDI-6 questionnaire score \< 4 * NIBUT ≥ 10 seconds. Exclusion Criteria: * Age \< 18 years * Pregnant or breastfeeding women * Individuals deprived of liberty by a judicial or administrative decision, and individuals hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under Article L1121-8, as well as individuals admitted to a healthcare or social institution for purposes other than research * Adults lacking legal capacity or unable to provide informed consent ; * Participants currently in the exclusion period of another research study; * All categories of individuals receiving special protection under French law are excluded from this research * Employees of Essilor International, Luxottica, GrandVision, or any of their subsidiaries. * Declared, untreated, and/or uncontrolled systemic disease that may affect vision (e.g., uncontrolled diabetes, uncontrolled hypertension); * Declared ocular disease, other than dry eye disease, with a significant impact on vision, such as visual field loss (e.g., glaucoma), reduced visual acuity, significant visual impairment in dim or bright environments (e.g., retinitis pigmentosa), corneal surface abnormalities including ectatic disorders (keratoconus, pellucid marginal degeneration), or corneal dystrophies (e.g., Fuchs dystrophy); * Declared autoimmune connective tissue disease or other condition known to cause dry eye disease (e.g., rheumatoid arthritis, rosacea, Crohn's disease, systemic lupus erythematosus, Graves' disease, Stevens-Johnson syndrome); * Active ocular or systemic allergy, or active ocular inflammatory condition such as keratitis, uveitis, blepharitis, etc.; * Declared neurological disorders, including a history of epilepsy, sensorimotor coordination disorders, ocular migraine, vestibular disease, or cerebellar disorders (e.g., balance disorders, nystagmus); * Binocular vision disorders such as strabismus, suppression, diplopia, amblyopia, or decompensated phorias associated with recurrent headaches, blurred or double vision, difficulty concentrating, or difficulties when frequently shifting focus between near and distance vision; * History of ocular surgery, refractive surgery, or ocular trauma; * Use of extended-wear contact lenses, rigid contact lenses, and/or orthokeratology lenses; * Prolonged wear of soft contact lenses (\>12 hours per day); * Use of medications that may influence vision or interfere with study assessments (e.g., antidepressants, tranquilizers, antipsychotics, oral retinoids, or medications with atropinic effects); * Ophthalmic treatments, light therapy, or other treatments for dry eye disease within the past 3 months, with the exception of over-the-counter eye drops not requiring a prescription, such as hyaluronic acid-based lubricants.

Primary outcome measure(s)

Contrast Sensitivity at Different Spatial Frequencies (logMAR) — From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Contrast sensitivity test: Participants are asked to identify patterns (such as stripes or letters) that become increasingly difficult to see
Non-Invasive Tear Breakup Time (NIBUT) (seconds) — From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Measurement of tear film stability by assessing the time it takes for the tear film to begin breaking up after a blink. Shorter times indicate a less stable tear film and may suggest dry eye disease. Measured with the IDRA instrument.
Visual Acuity (logMAR) — At day 1: At baseline
Measurement of the clarity and sharpness of vision using the logMAR scale. Lower logMAR values indicate better visual acuity and the ability to see finer details.
Area under the contrast sensitivity function curve (AULCSF) — From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Contrast sensitivity test: Participants are asked to identify patterns (such as stripes or letters) that become increasingly difficult to see
Scores on the OSDI-6 questionnaires — At day 1: At baseline
Assessment of dry eye disease symptoms and their impact on daily activities using the OSDI-6 questionnaire. It is the recommended questionnaire for dry eye disease. The questionnaire used six items. Each item is scored from 0 to 4 according to symptom frequency (0 = never, 1 = sometimes, 2 = often, 3 = mostly, 4 = constantly). The total score ranges from 0 to 24, with higher scores indicating more severe dry eye symptoms
Scores on the IOSS questionnaires — From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Assessment of the frequency and severity of symptoms related to dry eye disease using the IOSS questionnaire. The questionnaire used two items. Each item is scored from 0 (symptom never experienced) to 5 (very intense) with 1 (not intense at all). Higher scores indicate greater symptoms.
Blinking: frequency, duration, maximum interval, etc. — From enrollment to 7 days after enrollment: Before, after and during a digital eye strain task
Assessment of blinking behavior, including how often participants blink, how long each blink lasts, the maximum time between blinks, etc. These measures help evaluate visual fatigue and tear film stability during screen use. They will be measured with cameras and eyetracker.
Eye movements: saccades (amplitude, velocity, duration, frequency, latency, gain) — From enrollment to 7 days after enrollment: During a digital eye strain task
Assessment of rapid eye movements (saccades), including their amplitude, velocity, duration, frequency, reaction time, and accuracy. These measures provide information about visual behavior and the effects of visual fatigue. They will be measured with cameras and eyetracker.
Eye movements: fixations (position, duration, dispersion, number, frequency, stability, area) — From enrollment to 7 days after enrollment: During a digital eye strain task
Assessment of eye fixations, including where and how long participants look at an object an the screen, as well as the stability and distribution of their gaze. These measures help evaluate visual attention, reading behavior, and the effects of visual fatigue. They will be measured with cameras and eyetracker.

Trial sites (1)

Facility	City	Region	Status
Center of Neurosciences and Medical Research Essilor International	Paris	Paris

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07844408 on ClinicalTrials.gov ↗ ← All trials in France