ClinicalTrials.gg
RecruitingNCT05752214SOPIITAUpdated Mar 2, 2023

Quality of Life in Italian Visually Impaired Patients

An observational study in Visual Impairment, sponsored by Amore Filippo. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Amore Filippo · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Visual Impairment

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03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's planned enrollment of 500 is above the median of 126 across 97 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Amore Filippo is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Visually impaired subjects

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years of age.
  • Cognitive impairment that, in the opinion of the investigator, limits understanding of the or the questionnaire.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Group A

    Other: WEB Register

Interventions

  • OtherWEB 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.

06

What researchers measure

Primary outcomes

  1. VA-LV-VFQ-48 questionnaire score

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

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2021 (actual). Primary completion is estimated for Dec 2023, 31 months after the start.

Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 31 months is above that.

Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2023
First posted
Mar 2, 2023
StartActual
May 20, 2021
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2030
Last update
Mar 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05752214
Lead sponsor
Amore Filippo
Responsible party
Amore Filippo (Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Sponsor-investigator
First posted
Mar 2, 2023
Start date
May 20, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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