Visual Rehabilitation and Depression in Visually Impaired Patients with AMD

NCT06906003 | Recruiting

• 1 other identifier: RET 06-24
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks

• 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

  12 weeks

Interventions

visual rehabilitation program OTHER

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate and severe visually impaired patients affected by non exudative AMD

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead
• Sant'Alessio - Margherita di Savoia: collaborator

Study Sites (1)

IRCCS Fondazione G.B.Bietti

Rome, Italy, 00184, Italy

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Anxiety Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Mental Disorders

Central Study Contacts

Eliana Costanzo, MD

CONTACT

+390684009442; eliana.costanzo@fondazionebietti.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 2, 2025
• Study Start: December 2, 2024
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)