Visual Rehabilitation and Depression in Visually Impaired Patients With AMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: visual rehabilitation program.
- Who it may be relevant to
- Registry conditions: AMD - Age-Related Macular Degeneration, Anxiety, Depression Disorders. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients With Advanced Age Related Macular Degeneration
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program [Time frame: 12 weeks]
- Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Visual impairment due to other ocular diseases
- Mild visual impairment or partial or total blindness
- Exudative age-related macular degeneration undergoing intravitreal drug treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Fondazione G.B.Bietti — Rome
Identifiers
NCT: NCT06906003 · RET 06-24