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OpenTrials
Completed

NCT Number: NCT05151302

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computer vision symptom scale (CVSS) questionnaire

Diagnostic Test

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)

Primary outcomes

  1. To assess reliability (Cronbach alpha) of the CVSS

    Time frame: one year

    Cronbach alpha

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

    Time frame: one year

    statistical examinations

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2021
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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