Age-Related Macular Degeneration (ARMD) Clinical Trials

Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Fondazione G.B.Bietti
RECRUITING
Rome
Contact Information
Primary
Eliana Costanzo, MD
eliana.costanzo@fondazionebietti.it
+390684009442
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2025-12-02
Participants
Target number of participants: 22
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Fondazione G.B. Bietti, IRCCS
Collaborators: Sant'Alessio - Margherita di Savoia

This content was sourced from clinicaltrials.gov

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