Digital Eye StrainDESIROUSNCT05675475
Study of the Association Between Digital Eye Syndrome With Binocular Vision and the Ocular Surface in Higher Education Students in the Area of Health Technologies
An observational study of Digital Eye Strain, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
The goal of this observational study is to determinate the association between DES and changes in binocular vision and ocular surface. in higher education students in the area of health technologies. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Eye Strain
- What is being tested?
- Exposure, Orthoptic assessment (Outcome measure) and Tear film Break Up Time (BUT) test (Outcome measure)
- How many people
- 400 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2023to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Higher Education Students in the Area of Health Technologies.
Who may be able to join
- Students of the first, second and third year of the degrees offered by Lisbon School of Health Technology, Instituto Politécnico de Lisboa;
- Age between 18 to 39 years;
- Accept and sign the consent.
Who cannot join
- Working Students;
- Students with known binocular vision disorders;
- Previous eye surgeries.
Trial locations and contacts
1 site in 1 country.
Maria Barata, MSc contact
Portugal1 site
Escola Superior de Tecnologia de Saúde de Lisboa
Lisbon, 1990-096
Carla Lança, PhD, +351218980421, carla.costa@estesl.ipl.pt
Maria Barata, MSc, d52905@alunos.uevora.pt
About this study
The goal of this observational study is to determinate the association between DES and changes in binocular vision and ocular surface. in higher education students in the area of health technologies. The main questions it aims to determine the prevalence of Digital Eye Syndrome (DES); the association between DES and changes in binocular vision and ocular surface; whether the time of use and the type of electronic devices influences the degree and type of symptoms of DES; and to determine whether there is an association between the type of ametropia and the symptoms of DES. Participants will have to answer 3 questionnaires (the Computer Vision Syndrome Questionnaire; the Convergence Insufficiency Symptoms Survey, and the Dry Eye Questionnaire (DEQ-5)) and then they will perform an orthoptic assessment and an assessment of the ocular surface with the tear film Break Up Time (BUT) test.
- Conditions
- Digital Eye Strain
- Being tested
- Exposure, Orthoptic assessment (Outcome measure), Tear film Break Up Time (BUT) test (Outcome measure)
- Keywords
- accommodation, convergence, tear film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureOther
Higher education students from health technologies field exposed to digital devices.
Orthoptic assessment (Outcome measure)Diagnostic test
The orthoptic assessment is a non-invasive assessment that will last for 30 min to determine visual parameters related to binocular vision. It will be carried out by the research team in the orthoptics and vision sciences laboratories of the Lisbon School of Health Tecnology.
Tear film Break Up Time (BUT) test (Outcome measure)Diagnostic test
The BUT test is a tear film rupture assessment test that allows the stability of the tear film to be evaluated. To perform these tests, it is necessary to instill fluorescein and then it is observed in the slit lamp under illumination with a cobalt blue filter, to count the break-up time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Digital Eye Syndrome
To verify the existence or absence of digital fatigue syndrome in higher education students. For this purpose, the Computer Vision Syndrome Questionnaire will be used. To verify the existence or not of digital fatigue syndrome in higher education. The Computer Vision Syndrome Questionnaire (CVS-Q) will be applied, which is composed of 16 x 2 questions, to assess the symptoms and their intensity. This questionnaire makes it possible to classifying CVS as asymptomatic and symptomatic.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Secondary outcomes (16)
Convergence Insufficiency Symptoms Survey
The main objective of this questionnaire is to assess the frequency of symptoms of visual discomfort and consists of fifteen questions. The answers to the questions are evaluated and allow classifying binocular vision into "norm", "suspected convergence insufficiency" and "convergence insufficiency".
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Dry Eye Questionnaire (DEQ-5)
The DEQ-5 questionnaire is the reduced version of the DEQ questionnaire that allows the assessment of dry eye. this questionnaire is made up of 5 questions and allows to obtain an answer score that classifies as "normal" and "dry eye".
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Far Visual Acuity
Visual acuity is the spatial resolution capability of the visual system. The unit of measurement for this variable will be the minimum resolution angle algorithm (LogMAR).
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Visual Acuity
Visual acuity is the spatial resolution capability of the visual system. The unit of measurement for this variable will be the minimum resolution angle algorithm (LogMAR).
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Far Cover Test
The cover test is one of the variables used to study the motor component of the visual system and is a categorical variable, which will allow the identification of latent and manifest ocular deviations.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Cover Test
The cover test is one of the variables used to study the motor component of the visual system and is a categorical variable, which will allow the identification of latent and manifest ocular deviations.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Stereopsis
Stereopsis is one of the binocular vision parameters and the measurement unit used will be the arc seconds.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Point of Convergence
The near point of convergence is one of the convergence assessment methods and the unit of measurement is cm.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Flexibility of Accommodation
The flexibility of accommodation is one of the accommodation evaluation parameters and its measurement unit is cycle per minute.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Amplitude of Accommodation
The amplitude of accomodation is one of the accommodation evaluation parameters and its measurement unit is diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Far Convergence
The far convergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Convergence
The near convergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Near Divergence
The near divergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Far Divergence
The far divergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Break Up Time Test
The BUT Test will allow assessing the stability of the tear film and the unit of measurement will be seconds.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Refrative Error
The refractive error will be assessed using the auto refratometer and your measurements will be in diopters.
Measured: Immediately after subject enrollment, up to 1 week (single point collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Eye StrainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, University of Évora, CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Comprehensive Health Research Center (CHRC), Universidade Nova de Lisboa
- Responsible party
- Sponsor
- Investigators
- André Rosário, PhD, Principal investigator, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de LisboaCarla Lança, PhD, Principal investigator, Escola Superior de Tecnologia da Saúde de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675475
- Sponsor's protocol ID
- DESIROUS
- Acronym
- DESIROUS
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Digital Eye Syndrome With Binocular Vision and the Ocular Surface in Higher Education Students in the Area of Health Technologies
- ClinicalTrials.gov ID
- NCT05675475
- Acronym / sponsor ID
- DESIROUS / DESIROUS
- Conditions
- Digital Eye Strain
- Keywords
- accommodation, convergence, tear film
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa, University of Évora, CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Comprehensive Health Research Center (CHRC), Universidade Nova de Lisboa
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 9 Jan 2023 (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 determinate the association between DES and changes in binocular vision and ocular surface. in higher education students in the area of health technologies. The main questions it aims to determine the prevalence of Digital Eye Syndrome (DES); the association between DES and changes in binocular vision and ocular surface; whether the time of use and the type of electronic devices influences the degree and type of symptoms of DES; and to determine whether there is an association between the type of ametropia and the symptoms of DES. Participants will have to answer 3 questionnaires (the Computer Vision Syndrome Questionnaire; the Convergence Insufficiency Symptoms Survey, and the Dry Eye Questionnaire (DEQ-5)) and then they will perform an orthoptic assessment and an assessment of the ocular surface with the tear film Break Up Time (BUT) test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Higher Education Students in the Area of Health Technologies.
Key inclusion criteria (3 listed)
- Students of the first, second and third year of the degrees offered by Lisbon School of Health Technology, Instituto Politécnico de Lisboa;
- Age between 18 to 39 years;
- Accept and sign the consent.
Key exclusion criteria (3 listed)
- Working Students;
- Students with known binocular vision disorders;
- Previous eye surgeries.
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 |
|---|---|---|
| ExposureHigher education students from health technologies field exposed to digital devices. | Other | – |
| Orthoptic assessment (Outcome measure)The orthoptic assessment is a non-invasive assessment that will last for 30 min to determine visual parameters related to binocular vision. It will be carried out by the research team in the orthoptics and vision sciences laboratories of the Lisbon School of Health Tecnology. | Diagnostic test | – |
| Tear film Break Up Time (BUT) test (Outcome measure)The BUT test is a tear film rupture assessment test that allows the stability of the tear film to be evaluated. To perform these tests, it is necessary to instill fluorescein and then it is observed in the slit lamp under illumination with a cobalt blue filter, to count the break-up time. | Diagnostic test | – |
Primary outcome
Prevalence of Digital Eye Syndrome
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
To verify the existence or absence of digital fatigue syndrome in higher education students. For this purpose, the Computer Vision Syndrome Questionnaire will be used. To verify the existence or not of digital fatigue syndrome in higher education. The Computer Vision Syndrome Questionnaire (CVS-Q) will be applied, which is composed of 16 x 2 questions, to assess the symptoms and their intensity. This questionnaire makes it possible to classifying CVS as asymptomatic and symptomatic.
16 secondary outcomes
Convergence Insufficiency Symptoms Survey
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Dry Eye Questionnaire (DEQ-5)
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Far Visual Acuity
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Visual Acuity
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Far Cover Test
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Cover Test
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Stereopsis
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Point of Convergence
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Flexibility of Accommodation
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Amplitude of Accommodation
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Far Convergence
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Convergence
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Near Divergence
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Far Divergence
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Break Up Time Test
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Refrative Error
Time frame: Immediately after subject enrollment, up to 1 week (single point collection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maria Barata, MSc contact
André Rosário, PhD principal investigator
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Carla Lança, PhD principal investigator
Escola Superior de Tecnologia da Saúde de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Eye Strain, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Lança, PhD (+351218980421, carla.costa@estesl.ipl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Digital Eye Syndrome (time frame: Immediately after subject enrollment, up to 1 week (single point collection)). 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 9 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.