Quality of Life in Italian Visually Impaired Patients (SOPIITA)

February 21, 2023 updated by: Amore Filippo

Observational Study on Quality of Life in Visually Impaired Patients Through the Questionnaire VA LV VFQ in Italy

Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Visually impaired subjects

Description

Inclusion Criteria:

  • Subjects aged 18 years or older, suffering from any visual pathology, who are admitted to specialised visual rehabilitation centres for visual rehabilitation.
  • Ability to understand and sign the informed consent for participation in the study.

Exclusion Criteria:

  • Less than 18 years of age.
  • Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Other: WEB Register
Observational, non-profit, multicentre longitudinal study on the assessment of quality of life and its association with demographic variables and visual function of visually impaired patients attending the visual rehabilitation service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VA-LV-VFQ-48 questionnaire score
Time Frame: 10 years
Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amore Filippo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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