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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorEssilor International

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eye Exams

    Device

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

  • Ocular Biometry and Aberrometry

    Device

    Participants complete ocular aberrometric and biometric measurements.

  • Wearing a Smartwatch

    Device

    Participants wear an smartwatch to measure their physiological activity.

  • Wearing Visual Correction

    Device

    Participants are equipped with appropriate vision correction through spectacle lenses.

  • Eye-Blinking Tests

    Device

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

  • Retinal Examination

    Device

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

  • Assessment of Signs and Symptoms of Dry Eye

    Device

    Before and after a digital eye strain task, participants' signs and symptoms of dry eye are assessed.

  • Assessment of Digital Eye Strain Symptoms

    Device

    Before and after a digital eye strain task, participants assess their symptoms of digital eye strain.

  • Contrast Sensitivity Assessment

    Device

    Before and after a digital eye strain task, participants perform contrast sensitivity tests.

  • Digital Eye Strain Task

    Device

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Myopes with presence of signs and symptoms of dry eye diseaseExperimental treatment 10 interventions
Group B: Myopes without presence of signs and symptoms of dry eye diseaseExperimental treatment 10 interventions
Group C: Emmetropes with presence of signs and symptoms of dry eye diseaseExperimental treatment 9 interventions
Group D: Emmetropes without presence of signs and symptoms of dry eye diseaseExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Contrast Sensitivity at Different Spatial Frequencies (logMAR)

Contrast sensitivity test: Participants are asked to identify patterns (such as stripes or letters) that become increasingly difficult to see

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task
2

Non-Invasive Tear Breakup Time (NIBUT) (seconds)

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.

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task
3

Visual Acuity (logMAR)

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.

Time frame
At day 1: At baseline
4

Area under the contrast sensitivity function curve (AULCSF)

Contrast sensitivity test: Participants are asked to identify patterns (such as stripes or letters) that become increasingly difficult to see

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task

Secondary outcomes

1

Tear Meniscus Height (TMH) (millimeters)

Measurement of the height of the tear reservoir along the lower eyelid. TMH provides an indication of tear volume, with lower values suggesting reduced tear production and risks of dry eye disease. Measured with the IDRA instrument.

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task
2

Thickness of the lipid layer (nm)

Measurement of the thickness of the outer oily layer of the tear film, which helps prevent tear evaporation. Thinner lipid layers may indicate tear film instability and an increased risk of dry eye disease symptoms. Measured with the IDRA instrument.

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task
3

Ocular Redness Score

Assessment of eye redness by evaluating the appearance of blood vessels on the surface of the eye. Higher scores indicate greater ocular irritation and inflammation, which may be associated with dry eye disease or visual fatigue. Measured with IDRA instrument.

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task
4

Characteristics of the lipid layer (interferometry, colors, homogeneity, fringe pattern)

Assessment of the quality and structure of the tear film's outer lipid layer. Parameters such as color patterns, uniformity, and interference fringes provide information about tear film stability and the risk of dry eye disease. Measured with the IDRA instrument.

Time frame
From enrollment to 7 days after enrollment: Before and after a digital eye strain task

Other outcomes

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