Visual Rehabilitation and Depression in Visually Impaired Patients With AMD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorFondazione G.B. Bietti, IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Visual impairment due to other ocular diseases
Mild visual impairment or partial or total blindness
Exudative age-related macular degeneration undergoing intravitreal drug treatment
Trial population
Moderate and severe visually impaired patients affected by non exudative AMD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
visual rehabilitation program
Other interventionI. 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione G.B. Bietti, IRCCS
Lead sponsor
Sant'Alessio - Margherita di Savoia
Collaborator
Source ClinicalTrials.gov