Recruiting

Visual Rehabilitation and Depression in Visually Impaired Patients With AMD

ClinicalTrials.gov IDNCT06906003

PhaseNot Applicable

Enrollment22

SponsorFondazione G.B. Bietti, IRCCS

Age55 Years

SexALL

I'm interested View official listing

Conditions studied

AMD - Age-Related Macular Degeneration, Anxiety, Depression Disorders

About this study

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 outcomes

Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program (12 weeks)
Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program (12 weeks)

Eligibility information

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

Study locations

IRCCS Fondazione G.B.Bietti, Rome, Italy 00184 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.