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Visual Rehabilitation and Depression in Visually Impaired Patients With AMD

Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients With Advanced Age Related Macular Degeneration

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06906003
Acronym
RET 06-24
Enrollment
22
Registered
2025-04-02
Start date
2024-12-02
Completion date
2026-12-02
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Sponsors

Fondazione G.B. Bietti, IRCCS
Lead SponsorOTHER
Sant'Alessio - Margherita di Savoia
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program12 weeksGeneralised Anxiety Disorder score (GAD-7, range 0-21,higher scores mean worse outcome) changes after rehabilitation program

Countries

Italy

Contacts

CONTACTEliana Costanzo, MD
eliana.costanzo@fondazionebietti.it+390684009442

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026