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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05151302
Other study ID # CVSS17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2015
Est. completion date February 6, 2017

Study information

Verified date March 2022
Source IRCCS Policlinico S. Matteo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date February 6, 2017
Est. primary completion date February 6, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Outcome

Type Measure Description Time frame Safety issue
Primary To assess reliability (Cronbach alpha) of the CVSS Cronbach alpha one year
Secondary 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
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