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 (DESIROUS)

December 27, 2022 updated by: Universidade Nova de Lisboa
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Higher Education Students in the Area of Health Technologies.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Working Students;
  • Students with known binocular vision disorders;
  • Previous eye surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after subject enrollment, up to 1 week (single point collection)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Convergence Insufficiency Symptoms Survey
Time Frame: Immediately after subject enrollment, up to 1 week (single point collection)
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".
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)
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".
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)
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).
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)
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).
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)
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.
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)
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.
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)
Stereopsis is one of the binocular vision parameters and the measurement unit used will be the arc seconds.
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)
The near point of convergence is one of the convergence assessment methods and the unit of measurement is cm.
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)
The flexibility of accommodation is one of the accommodation evaluation parameters and its measurement unit is cycle per minute.
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)
The amplitude of accomodation is one of the accommodation evaluation parameters and its measurement unit is diopters.
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)
The far convergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
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)
The near convergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
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)
The near divergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
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)
The far divergence is one of the elements of fusional vergencies and its measurement unit is the prismatic diopters.
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)
The BUT Test will allow assessing the stability of the tear film and the unit of measurement will be seconds.
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)
The refractive error will be assessed using the auto refratometer and your measurements will be in diopters.
Immediately after subject enrollment, up to 1 week (single point collection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Nova de Lisboa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Évora
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Escola Superior de Tecnologia da Saúde de Lisboa (ESTeSL)
CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Comprehensive Health Research Center (CHRC), Universidade Nova de Lisboa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: André Rosário, PhD, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
  • Principal Investigator: Carla Lança, PhD, Escola Superior de Tecnologia da Saúde de Lisboa (ESTeSL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2022

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DESIROUS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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