Actively Recruiting
Visual Rehabilitation and Depression in Visually Impaired Patients with AMD
Led by Fondazione G.B. Bietti, IRCCS · Updated on 2025-04-02
22
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
F
Fondazione G.B. Bietti, IRCCS
Lead Sponsor
S
Sant'Alessio - Margherita di Savoia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Visual Rehabilitation and Depression in Visually Impaired Patients with AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Moderate to severe visual impairment (best-corrected visual acuity between 1/10 and 2/10)
- Diagnosis of advanced non-exudative age-related macular degeneration (AMD)
- Provided informed consent before starting the study
- Ability to understand and willingness to follow study instructions and procedures
You will not qualify if you...
- Visual impairment caused by other eye diseases
- Mild visual impairment or partial or total blindness
- Exudative age-related macular degeneration currently treated with intravitreal drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Fondazione G.B.Bietti
Rome, Italy, Italy, 00184
Actively Recruiting
Research Team
E
Eliana Costanzo, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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