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)

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: Not yet recruiting
• Conditions: Digital Eye Strain
• Intervention / Treatment: Other: Exposure; Diagnostic test: Orthoptic assessment (Outcome measure); Diagnostic test: Tear film Break Up Time (BUT) test (Outcome measure)

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Carla Lança, PhD; Phone Number: +351218980421; Email: carla.costa@estesl.ipl.pt
• Study Contact Backup: Name: Maria Barata, MSc; Email: d52905@alunos.uevora.pt

Study Locations

• Portugal
  • Lisboa, Portugal, 1990-096
    • Escola Superior de Tecnologia de Saúde de Lisboa
    • Contact: Carla Lança, PhD; Phone Number: +351218980421; Email: carla.costa@estesl.ipl.pt
    • Contact: Maria Barata, MSc; Email: d52905@alunos.uevora.pt

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after subject enrollment, up to 1 week (single point collection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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".	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Immediately after subject enrollment, up to 1 week (single point collection)

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa
• Collaborators: 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: 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

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Estimate): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: tear film; accommodation; convergence
• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID 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