NCT06906003Recruiting
Visual Rehabilitation and Depression in Visually Impaired Patients With AMD
Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients With Advanced Age Related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status. Study design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia. Study procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9). Visit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings. Visit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 22 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 2 Dec 2024
- Primary completion date
- 2 Dec 2026
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Diseases
- Macular degeneration
- NCT number
- NCT06906003
What you commit to
- Study type: Observational
- Planned participants: 22
- From 2 Dec 2024 to the primary completion date, 2 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Visual impairment due to other ocular diseases
- Mild visual impairment or partial or total blindness
Age
- Exudative age-related macular degeneration undergoing intravitreal drug treatment
Who the study is looking for
- Subjects ≥ 55 years
- Moderate and severe visual impairment (BCVA ≥1/10 and ≤2/10)
- Diagnosis of advanced non-exudative age-related macular degeneration (AMD)
- Informed consent freely granted and acquired before the start of the study
- Ability to understand and willingness to follow the study instructions and procedures
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irccs Fondazione G. B. Bietti Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.