MyopiaRReyeNCT07844408
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
A study testing Eye Exams, Ocular Biometry and Aberrometry and Wearing a Smartwatch in people with Myopia and Dry Eye Disease (DED), run by Essilor International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Dry Eye Disease (DED)
- What is being tested?
- Eye Exams, Ocular Biometry and Aberrometry and Wearing a Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Center of Neurosciences and Medical Research Essilor International
Paris, Paris, 75012
Delphine Tranvouez-Bernardin, +33 1 55 96 47 04, tranvoud@essilor.fr
About this study
Official title: Étude du Comportement Visuel et de la Qualité Visuelle Induits Par la Fatigue Oculaire Numérique Chez Les Personnes Emmétropes et Myopes Présentant ou Non Des Signes et Symptômes de Sécheresse Oculaire
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?
Read more
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.
- Conditions
- Myopia, Dry Eye Disease (DED)
- Being tested
- Eye Exams, Ocular Biometry and Aberrometry, Wearing a Smartwatch, Wearing Visual Correction, Eye-Blinking Tests
- Keywords
- Dry eye disease, Myopia, Contrast sensitivity, Screen use, Blink
- Medical subject headings
- Myopia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye ExamsDevice
Participants undergo several visual examinations (visual function, visual refraction, visual acuity).
Ocular Biometry and AberrometryDevice
Participants complete ocular aberrometric and biometric measurements.
Wearing a SmartwatchDevice
Participants wear an smartwatch to measure their physiological activity.
Wearing Visual CorrectionDevice
Participants are equipped with appropriate vision correction through spectacle lenses.
Eye-Blinking TestsDevice
Before and after a digital eye strain task, participants perform eye-blinking tests on a screen.
Retinal ExaminationDevice
Before and after a digital eye strain task, participants undergo a retinal examination.
Assessment of Signs and Symptoms of Dry EyeDevice
Before and after a digital eye strain task, participants' signs and symptoms of dry eye are assessed.
Assessment of Digital Eye Strain SymptomsDevice
Before and after a digital eye strain task, participants assess their symptoms of digital eye strain.
Contrast Sensitivity AssessmentDevice
Before and after a digital eye strain task, participants perform contrast sensitivity tests.
Digital Eye Strain TaskDevice
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 group | Role | What they receive |
|---|---|---|
| Myopes with presence of signs and symptoms of dry eye disease | Experimental | Not described Receives: Device: Eye Exams; Device: Ocular Biometry and Aberrometry; Device: Wearing a Smartwatch; Device: Wearing Visual Correction; Device: Eye-Blinking Tests; Device: Retinal Examination; Device: Assessment of Signs and Symptoms of Dry Eye; Device: Assessment of Digital Eye Strain Symptoms; Device: Contrast Sensitivity Assessment; Device: Digital Eye Strain Task |
| Myopes without presence of signs and symptoms of dry eye disease | Experimental | Not described Receives: Device: Eye Exams; Device: Ocular Biometry and Aberrometry; Device: Wearing a Smartwatch; Device: Wearing Visual Correction; Device: Eye-Blinking Tests; Device: Retinal Examination; Device: Assessment of Signs and Symptoms of Dry Eye; Device: Assessment of Digital Eye Strain Symptoms; Device: Contrast Sensitivity Assessment; Device: Digital Eye Strain Task |
| Emmetropes with presence of signs and symptoms of dry eye disease | Experimental | Not described Receives: Device: Eye Exams; Device: Ocular Biometry and Aberrometry; Device: Wearing a Smartwatch; Device: Eye-Blinking Tests; Device: Retinal Examination; Device: Assessment of Signs and Symptoms of Dry Eye; Device: Assessment of Digital Eye Strain Symptoms; Device: Contrast Sensitivity Assessment; Device: Digital Eye Strain Task |
| Emmetropes without presence of signs and symptoms of dry eye disease | Experimental | Not described Receives: Device: Eye Exams; Device: Ocular Biometry and Aberrometry; Device: Wearing a Smartwatch; Device: Eye-Blinking Tests; Device: Retinal Examination; Device: Assessment of Signs and Symptoms of Dry Eye; Device: Assessment of Digital Eye Strain Symptoms; Device: Contrast Sensitivity Assessment; Device: Digital Eye Strain Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
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.
Measured: At day 1: At baseline
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
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Scores on the OSDI-6 questionnaires
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
Measured: At day 1: At baseline
Scores on the IOSS questionnaires
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Blinking: frequency, duration, maximum interval, etc.
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.
Measured: From enrollment to 7 days after enrollment: Before, after and during a digital eye strain task
Eye movements: saccades (amplitude, velocity, duration, frequency, latency, gain)
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.
Measured: From enrollment to 7 days after enrollment: During a digital eye strain task
Eye movements: fixations (position, duration, dispersion, number, frequency, stability, area)
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.
Measured: From enrollment to 7 days after enrollment: During a digital eye strain task
Secondary outcomes (19)
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
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.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Screen time since waking up (hours)
Measurement of the total time spent using digital screens since waking up on the day of the assessment. This measure helps evaluate the potential impact of screen exposure on visual fatigue and dry eye disease symptoms.
Measured: From enrollment to 7 days after enrollment: At the start of each visit
Weekly screen time (hours)
Measurement of the average number of hours spent using digital screens each week across all devices. This measure helps assess long-term screen exposure and its potential impact on visual fatigue and dry eye disease symptoms.
Measured: At day 1: At baseline
Score on the Digital Eye Strain Questionnaire
Assessment of symptoms related to digital eye strain, such as eye discomfort, blurred vision, headaches, and visual fatigue. Each symptom is rated on a scale from 0 to 10, where 0 indicates no symptoms, 1 indicates very mild symptoms, and 10 indicates very severe symptoms. Higher scores indicate more severe symptoms.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Optical quality: Total optical aberration (total RMS, micrometers), High-order optical aberration (RMS HOAs and per order, micrometers)
Assessment of the optical quality of the eye by measuring imperfections that affect image clarity. Total aberrations reflect overall optical distortion, while higher-order aberrations assess more subtle distortions that can reduce visual quality. Measured with a Pentacam AXL.
Measured: At day 1: At baseline
Accommodative measurements: PPA (centimeters) or AA (diopters), Accommodative rock (cycles/degree)
Assessment of the eye's ability to focus on near objects and rapidly switch focus between different distances. These measures provide information about visual flexibility, focusing performance, and visual fatigue. Measured with optometric instruments.
Measured: At day 1: At baseline
Cardiac activity (ECG) (beats per minute, variability in ms/Hz, interval between beats, etc.)
Measurement of heart activity, including heart rate, heart rate variability, and the time between heartbeats. These parameters provide information about physiological responses to stress, mental workload, and visual fatigue during the study. Measured with a smartwatch.
Measured: From enrollment to 7 days after enrollment: Before, after and during a digital eye strain task
Electrodermal activity (EDA) (frequency of phasic responses, conductance-level and response.)
Measurement of changes in skin conductance, including baseline levels and rapid responses to stimuli. These parameters reflect physiological arousal, stress, and cognitive workload, providing insight into the body's response to visual tasks and fatigue. Measured with a smartwatch.
Measured: Before, after and during a digital eye strain task
Mitochondrial activity: autofluorescence score (FPF intensity, FPF heterogeneity)
Assessment of mitochondrial function by measuring flavoprotein autofluorescence (FPF) in the eye. FPF intensity and heterogeneity provide indicators of cellular metabolic activity and oxidative stress, which may reflect changes in ocular health and visual fatigue. Measured with an OcuScience device.
Measured: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Reading speed (number of words read per minute)
Measurement of the number of words read per minute, providing an indicator of reading performance, and the potential impact of visual fatigue and dry eye disease on reading ability.
Measured: From enrollment to 7 days after enrollment: During a digital eye strain task
Errors made during the digital eye strain task (number of actions not taken and actions taken incorrectly)
Measurement of the number of mistakes made during the screen task. This outcome provides an indicator of attention, task performance, and the effects of visual fatigue and dry eye disease on accuracy.
Measured: From enrollment to 7 days after enrollment: During a digital eye strain task
Biometry: Choroidal thickness (microns)
Measurement of the thickness of the choroid. Measured with spectral domain optical coherence tomography (OCT B-scan)
Measured: At day 1: At baseline
Biometry: Vascular density percentage (%)
Measurement of the vascular density percentage of the retina. Measured with spectral domain optical coherence tomography (OCT B-scan). Used to evaluate retinal blood vessel perfusion and microvascular health.
Measured: At day 1: At baseline
Biometry: Foveal avascular zone (mm²)
Measurement of the size of the central retinal area devoid of blood vessels, located at the fovea. Measured with optical coherence tomography angiography (OCTA). This measure is used to assess retinal microvascular integrity.
Measured: At day 1: At baseline
Biometry: Axial length (mm)
Measurement of the distance from the anterior surface of the cornea to the retinal pigment epithelium along the eye's optical axis, expressed in millimeters. Measured using Pentacam AXL. This measure is used to assess ocular size.
Measured: At day 1: At baseline
Biometry: Pupillary diameter (mm)
Measurement of the diameter of the pupil, expressed in millimeters. Measured using Pentacam AXL under standardized lighting conditions. This measure is used to assess pupillary function.
Measured: At day 1: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844408
- Sponsor's protocol ID
- WS10509
- Other IDs
- 2026-A00841-50
- Acronym
- RReye
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude du Comportement Visuel et de la Qualité Visuelle Induits Par la Fatigue Oculaire Numérique Chez Les Personnes Emmétropes et Myopes Présentant ou Non Des Signes et Symptômes de Sécheresse Oculaire
- ClinicalTrials.gov ID
- NCT07844408
- Acronym / sponsor ID
- RReye / WS10509
- Conditions
- Myopia, Dry Eye Disease (DED)
- Keywords
- Dry eye disease, Myopia, Contrast sensitivity, Screen use, Blink
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myopes with presence of signs and symptoms of dry eye disease | Experimental | Device: Eye Exams, Device: Ocular Biometry and Aberrometry, Device: Wearing a Smartwatch, Device: Wearing Visual Correction, Device: Eye-Blinking Tests, Device: Retinal Examination, Device: Assessment of Signs and Symptoms of Dry Eye, Device: Assessment of Digital Eye Strain Symptoms, Device: Contrast Sensitivity Assessment, Device: Digital Eye Strain Task |
| Myopes without presence of signs and symptoms of dry eye disease | Experimental | Device: Eye Exams, Device: Ocular Biometry and Aberrometry, Device: Wearing a Smartwatch, Device: Wearing Visual Correction, Device: Eye-Blinking Tests, Device: Retinal Examination, Device: Assessment of Signs and Symptoms of Dry Eye, Device: Assessment of Digital Eye Strain Symptoms, Device: Contrast Sensitivity Assessment, Device: Digital Eye Strain Task |
| Emmetropes with presence of signs and symptoms of dry eye disease | Experimental | Device: Eye Exams, Device: Ocular Biometry and Aberrometry, Device: Wearing a Smartwatch, Device: Eye-Blinking Tests, Device: Retinal Examination, Device: Assessment of Signs and Symptoms of Dry Eye, Device: Assessment of Digital Eye Strain Symptoms, Device: Contrast Sensitivity Assessment, Device: Digital Eye Strain Task |
| Emmetropes without presence of signs and symptoms of dry eye disease | Experimental | Device: Eye Exams, Device: Ocular Biometry and Aberrometry, Device: Wearing a Smartwatch, Device: Eye-Blinking Tests, Device: Retinal Examination, Device: Assessment of Signs and Symptoms of Dry Eye, Device: Assessment of Digital Eye Strain Symptoms, Device: Contrast Sensitivity Assessment, Device: Digital Eye Strain Task |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye ExamsParticipants undergo several visual examinations (visual function, visual refraction, visual acuity). | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Ocular Biometry and AberrometryParticipants complete ocular aberrometric and biometric measurements. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Wearing a SmartwatchParticipants wear an smartwatch to measure their physiological activity. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Wearing Visual CorrectionParticipants are equipped with appropriate vision correction through spectacle lenses. | Device | Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Eye-Blinking TestsBefore and after a digital eye strain task, participants perform eye-blinking tests on a screen. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Retinal ExaminationBefore and after a digital eye strain task, participants undergo a retinal examination. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Assessment of Signs and Symptoms of Dry EyeBefore and after a digital eye strain task, participants' signs and symptoms of dry eye are assessed. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Assessment of Digital Eye Strain SymptomsBefore and after a digital eye strain task, participants assess their symptoms of digital eye strain. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Contrast Sensitivity AssessmentBefore and after a digital eye strain task, participants perform contrast sensitivity tests. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
| Digital Eye Strain TaskParticipants 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. | Device | Emmetropes with presence of signs and symptoms of dry eye disease, Emmetropes without presence of signs and symptoms of dry eye disease, Myopes with presence of signs and symptoms of dry eye disease, Myopes without presence of signs and symptoms of dry eye disease |
Primary outcome
Contrast Sensitivity at Different Spatial Frequencies (logMAR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
19 secondary outcomes
Tear Meniscus Height (TMH) (millimeters)
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Thickness of the lipid layer (nm)
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Ocular Redness Score
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Characteristics of the lipid layer (interferometry, colors, homogeneity, fringe pattern)
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Screen time since waking up (hours)
Time frame: From enrollment to 7 days after enrollment: At the start of each visit
Weekly screen time (hours)
Time frame: At day 1: At baseline
Score on the Digital Eye Strain Questionnaire
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Optical quality: Total optical aberration (total RMS, micrometers), High-order optical aberration (RMS HOAs and per order, micrometers)
Time frame: At day 1: At baseline
Accommodative measurements: PPA (centimeters) or AA (diopters), Accommodative rock (cycles/degree)
Time frame: At day 1: At baseline
Cardiac activity (ECG) (beats per minute, variability in ms/Hz, interval between beats, etc.)
Time frame: From enrollment to 7 days after enrollment: Before, after and during a digital eye strain task
Electrodermal activity (EDA) (frequency of phasic responses, conductance-level and response.)
Time frame: Before, after and during a digital eye strain task
Mitochondrial activity: autofluorescence score (FPF intensity, FPF heterogeneity)
Time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task
Reading speed (number of words read per minute)
Time frame: From enrollment to 7 days after enrollment: During a digital eye strain task
Errors made during the digital eye strain task (number of actions not taken and actions taken incorrectly)
Time frame: From enrollment to 7 days after enrollment: During a digital eye strain task
Biometry: Choroidal thickness (microns)
Time frame: At day 1: At baseline
Biometry: Vascular density percentage (%)
Time frame: At day 1: At baseline
Biometry: Foveal avascular zone (mm²)
Time frame: At day 1: At baseline
Biometry: Axial length (mm)
Time frame: At day 1: At baseline
Biometry: Pupillary diameter (mm)
Time frame: At day 1: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Exams, Ocular Biometry and Aberrometry and Wearing a Smartwatch in people with Myopia and Dry Eye Disease (DED), run by Essilor International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Tranvouez-Bernardin (+33 1 55 96 47 04, tranvoud@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Sensitivity at Different Spatial Frequencies (logMAR) (time frame: From enrollment to 7 days after enrollment: Before and after a digital eye strain task). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.