The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.

Video display terminal users frequently refer computer-related visual and ocular symptoms, that are the most frequently occurring health problems among such these subjects.

The Italian law has established an eye examination to assess ocular status (D.Lgs 81/08 ex law 626/96) in VDT workers: subjects are evaluated by clinical signs and symptoms. The availability of a validated questionnaire could be very useful to diagnose visual disturbances and to follow them during follow-up examinations in 2014, a Spanish group has developed and validated a questionnaire for the assessment of visual and ocular symptoms in VDT workers.

Aim of the present study is to make available to Italian health professionals a new instrument to assess asthenopic symptoms, taking into account the patient's perspective.

Study Overview

• Status: Completed
• Conditions: Computer Vision Syndrome; Video Display Terminal Workers
• Intervention / Treatment: Diagnostic test: computer vision symptom scale (CVSS) questionnaire

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• VDT workers as defined by the Italian law (>20 hours a week on PC); in the control group patients no VDT workers.
• VDT workers at the Foundation or VDT accessing to the general service of the Clinic for a routine visit (VDT group)
• patients, not working at VDT, accessing to the "general service" of the eye clinic to perform a routine visit will be asked to participate the study (control group)
• no ocular surgery in the preceding 6 months
• written consent to participate to study procedures and personal data utilization in an encoded form

Exclusion Criteria:

• ocular surgery in the preceding 6 months
• patients unable to respond to questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: completion of the computer vision symptom scale questionnaire, italian version; video display terminal (VDT) workers completed the questionnaire

Diagnostic test: computer vision symptom scale (CVSS) questionnaire; Subjects working at VDT for >20 hours a week and accessing to the Eye Clinic in order to complete an ocular examination and subjects working at the Foundation accessing to the Eye Clinic in order to complete an ocular status evaluation according to Italian Law 81/08 will be asked to self-complete the questionnaire in presence of the attending junior ophthalmologists prior to the visit with the Ophthalmologist, to avoid interference with visit results (communication of bad/good news)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess reliability (Cronbach alpha) of the CVSS	Cronbach alpha	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess: -item internal consistency -equality of item-scale correlations -item discriminant validity -temporal stability -discriminating ability (between VDT and non-VDT workers) -external validity	statistical examinations	one year

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Gemma Caterina M Rossi, irccs policlinico san matteo foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2015
• Primary Completion (Actual): February 6, 2017
• Study Completion (Actual): February 6, 2017

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CVSS17

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
• product manufactured in and exported from the U.S.: No