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NCT Number: NCT06906003

Visual Rehabilitation and Depression in Visually Impaired Patients With AMD

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.

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Key information

Conditions

AMD - Age-Related Macular Degeneration Anxiety Anxiety Disorders Depression Disorders Eye Diseases Macular Degeneration Mental Disorders Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program

    Time frame: 12 weeks

    Generalised Anxiety Disorder score (GAD-7, range 0-21,higher scores mean worse outcome) changes after rehabilitation program

  2. Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program

    Time frame: 12 weeks

    Patient Health Questionnaire score (PHQ-9, range 0-27, higher scores mean worse outcome) changes after rehabilitation program

Study contacts

Contact information is provided by the study sponsor or research team.

Eliana Costanzo, MD

CONTACT

[email protected]

+390684009442

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Collaborators

  • Sant'Alessio - Margherita di Savoia

Registry information

Official study title

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

Acronym: RET 06-24

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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