An observational study in AMD - Age-Related Macular Degeneration, Anxiety and Depression Disorders, sponsored by Fondazione G.B. Bietti, IRCCS. Recruiting at 1 site in Italy. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Fondazione G.B. Bietti, IRCCS · Observational
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 22 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Fondazione G.B. Bietti, IRCCS is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate and severe visually impaired patients affected by non exudative AMD
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
I. meeting: coin recognition II. meeting: reading stories and audio books' listening III. meeting: installation of APPs on their smartphones and tablets and use of voice assistant IV. meeting: management of "table" activities V. meeting: meeting with caregivers.
Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program
Generalised Anxiety Disorder score (GAD-7, range 0-21,higher scores mean worse outcome) changes after rehabilitation program
Time frame: 12 weeks
Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program
Patient Health Questionnaire score (PHQ-9, range 0-27, higher scores mean worse outcome) changes after rehabilitation program
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
Of 104 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's planned 24 months is below that.
Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Fondazione G.B. Bietti, IRCCS