Video Display Terminal WorkersNCT05151302
The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.
A study testing computer vision symptom scale (CVSS) questionnaire in people with Video Display Terminal Workers and Computer Vision Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Video Display Terminal Workers, Computer Vision Syndrome
- What is being tested?
- computer vision symptom scale (CVSS) questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2015to 6 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ocular surgery in the preceding 6 months
- patients unable to respond to questionnaire
About this study
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.
- Being tested
- computer vision symptom scale (CVSS) questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer vision symptom scale (CVSS) questionnaireDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| completion of the computer vision symptom scale questionnaire, italian version | Other | video display terminal (VDT) workers completed the questionnaire Receives: Diagnostic Test: computer vision symptom scale (CVSS) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess reliability (Cronbach alpha) of the CVSS
Cronbach alpha
Measured: 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
statistical examinations
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start11 Feb 2015
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Display Terminal WorkersStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Caterina Maria Rossi, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Gemma Caterina M Rossi, Principal investigator, irccs policlinico san matteo foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151302
- Sponsor's protocol ID
- CVSS17
- Status last verified
- Mar 2022
- First submitted
- 11 Nov 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.
- ClinicalTrials.gov ID
- NCT05151302
- Acronym / sponsor ID
- CVSS17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| completion of the computer vision symptom scale questionnaire, italian version | Other | Diagnostic Test: computer vision symptom scale (CVSS) questionnairevideo display terminal (VDT) workers completed the questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- ocular surgery in the preceding 6 months
- patients unable to respond to questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer vision symptom scale (CVSS) questionnaireSubjects 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) | Diagnostic test | completion of the computer vision symptom scale questionnaire, italian version |
Primary outcome
To assess reliability (Cronbach alpha) of the CVSS
Time frame: one year
Cronbach alpha
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Caterina M Rossi principal investigator
irccs policlinico san matteo foundation
Questions about this trial
What is this clinical trial studying?
A study testing computer vision symptom scale (CVSS) questionnaire in people with Video Display Terminal Workers and Computer Vision Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess reliability (Cronbach alpha) of the CVSS (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.