NCT06906003 Visual Rehabilitation and Depression in Visually Impaired Patients With AMD
| NCT ID | NCT06906003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione G.B. Bietti, IRCCS |
| Condition | AMD - Age-Related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 22 participants in total. It began in 2024-12-02 with a primary completion date of 2026-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06906003 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying AMD - Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906003 currently recruiting?
Yes, NCT06906003 is actively recruiting participants. Contact the research team at eliana.costanzo@fondazionebietti.it for enrollment information.
Where is the NCT06906003 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06906003 clinical trial?
NCT06906003 is sponsored by Fondazione G.B. Bietti, IRCCS. The trial plans to enroll 22 participants.