Visual Rehabilitation and Depression in Visually Impaired Patients with AMD
NCT ID: NCT06906003
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
22 participants
OBSERVATIONAL
2024-12-02
2025-12-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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visual rehabilitation program
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.
Eligibility Criteria
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Inclusion Criteria
2. Moderate and severe visual impairment (BCVA ≥1/10 and ≤2/10)
3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)
4. Informed consent freely granted and acquired before the start of the study
5. Ability to understand and willingness to follow the study instructions and procedures
Exclusion Criteria
2. Mild visual impairment or partial or total blindness
3. Exudative age-related macular degeneration undergoing intravitreal drug treatment
55 Years
ALL
No
Sponsors
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Sant'Alessio - Margherita di Savoia
OTHER
Fondazione G.B. Bietti, IRCCS
OTHER
Responsible Party
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Locations
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IRCCS Fondazione G.B.Bietti
Rome, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RET 06-24
Identifier Type: -
Identifier Source: org_study_id
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