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

Digital Eye Strain Clinical Trial

— DESIROUS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675475
• Other study ID #: DESIROUS
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Universidade Nova de Lisboa
• Contact: Carla Lança, PhD
• Phone: +351218980421
• Email: carla.costa[@]estesl.ipl.pt
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthenopia
• Digital Eye Strain

Intervention

Other:
• Exposure
Higher education students from health technologies field exposed to digital devices.

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Portugal	Escola Superior de Tecnologia de Saúde de Lisboa	Lisboa

Sponsors (6)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Comprehensive Health Research Center (CHRC), Universidade Nova de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa (ESTeSL), NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa, University of Évora

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)