Visual ImpairmentSOPIITANCT05752214
Quality of Life in Italian Visually Impaired Patients
An observational study of Visual Impairment, run by Amore Filippo at 1 site in Italy.
Trial summary
Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment
- What is being tested?
- WEB Register
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2021to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Visually impaired subjects
Who may be able to join
- 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.
Who cannot join
- Less than 18 years of age.
- Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Filippo Amore, MD, +39 06 35510819, f.amore@iapb.it
About this study
Official title: 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
- Conditions
- Visual Impairment
- Being tested
- WEB Register
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB RegisterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Not described Receives: Other: WEB Register |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Amore Filippo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amore Filippo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752214
- Sponsor's protocol ID
- 3904
- Acronym
- SOPIITA
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Quality of Life in Visually Impaired Patients Through the Questionnaire VA LV VFQ in Italy
- ClinicalTrials.gov ID
- NCT05752214
- Acronym / sponsor ID
- SOPIITA / 3904
- Conditions
- Visual Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Amore FilippoUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Mar 2023 (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.
Clinical register of visual rehabilitation activity and observational study on the validation of the VA LV VFQ questionnaire in the Italian context
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: WEB Register |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Visually impaired subjects
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Less than 18 years of age.
- Cognitive impairment that, in the opinion of the investigator, limits understanding of the informed consent or the 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 |
|---|---|---|
| WEB RegisterObservational, 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. | Other | Group A |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment, run by Amore Filippo at 1 site in Italy.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VA-LV-VFQ-48 questionnaire score (time frame: 10 years). 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 2 Mar 2023.