NCT05675475

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

December 12, 2022

Last Update Submit

December 27, 2022

Conditions

Keywords

accommodationconvergencetear film

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Convergence Insufficiency Symptoms Survey

    Immediately after subject enrollment, up to 1 week (single point collection)

  • Dry Eye Questionnaire (DEQ-5)

    Immediately after subject enrollment, up to 1 week (single point collection)

  • Far Visual Acuity

    Immediately after subject enrollment, up to 1 week (single point collection)

  • Near Visual Acuity

    Immediately after subject enrollment, up to 1 week (single point collection)

  • Far Cover Test

    Immediately after subject enrollment, up to 1 week (single point collection)

  • +11 more secondary outcomes

Interventions

Higher education students from health technologies field exposed to digital devices.

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.

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.

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Higher Education Students in the Area of Health Technologies.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Tecnologia de Saúde de Lisboa

Lisbon, 1990-096, Portugal

Location

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Barata, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

January 9, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

January 9, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations