NCT05151302

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

February 11, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

May 1, 2025

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

November 11, 2021

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess reliability (Cronbach alpha) of the CVSS

    Cronbach alpha

    one year

Secondary Outcomes (1)

  • 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

Study Arms (1)

completion of the computer vision symptom scale questionnaire, italian version

OTHER

video display terminal (VDT) workers completed the questionnaire

Diagnostic Test: computer vision symptom scale (CVSS) questionnaire

Interventions

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)

completion of the computer vision symptom scale questionnaire, italian version

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gemma Caterina M Rossi

    irccs policlinico san matteo foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 9, 2021

Study Start

February 11, 2015

Primary Completion

February 6, 2017

Study Completion

February 6, 2017

Last Updated

May 1, 2025

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share