Visual Rehabilitation and Depression in Visually Impaired Patients with AMD (RET 06-24)

Fondazione G.B. Bietti, IRCCS

Status: Enrolling

Conditions: AMD - Age-Related Macular Degeneration; Depression Disorders; Anxiety

Treatments: Other: visual rehabilitation program

Study type: Observational

Funder types: Other

Identifiers

NCT06906003

RET 06-24

Details and patient eligibility

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects ≥ 55 years
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

1. Visual impairment due to other ocular diseases
2. Mild visual impairment or partial or total blindness
3. Exudative age-related macular degeneration undergoing intravitreal drug treatment