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

Sponsor

IRCCS Policlinico S. Matteo (Other)

Overall Status

Completed

CT.gov ID

NCT05151302

Collaborator

(none)

216

Enrollment

Arm

23.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Video Display Terminal Workers Computer Vision Syndrome	Diagnostic Test: computer vision symptom scale (CVSS) questionnaire	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 11, 2015

Actual Primary Completion Date :

Feb 6, 2017

Actual Study Completion Date :

Feb 6, 2017

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

To assess reliability (Cronbach alpha) of the CVSS [one year]
Cronbach alpha

Secondary Outcome Measures

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 [one year]
statistical examinations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

Investigators

Principal Investigator: Gemma Caterina M Rossi, irccs policlinico san matteo foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rossi, Gemma Caterina Maria, principal investigator, IRCCS Policlinico S. Matteo

ClinicalTrials.gov Identifier:

NCT05151302

Other Study ID Numbers:

CVSS17

First Posted:

Dec 9, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2022