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

May 29, 2026 updated by: Fondazione G.B. Bietti, IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Moderate and severe visually impaired patients affected by non exudative AMD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione G.B. Bietti, IRCCS

Collaborators

Sant'Alessio - Margherita di Savoia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 2, 2026

Study Completion (Estimated)

December 2, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RET 06-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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