SOPIITA: Quality of Life in Italian Visually Impaired Patients

Sponsor

Amore Filippo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05752214

Collaborator

(none)

500

Enrollment

Location

115.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment	Other: WEB Register

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

VA-LV-VFQ-48 questionnaire score [10 years]
Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma		Italy	00168

Sponsors and Collaborators

Amore Filippo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amore Filippo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05752214

Other Study ID Numbers:

3904

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vision Disorders

Vision, Low

Study Results

No Results Posted as of Mar 2, 2023