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Charles Bonnet Syndrome in Low Vision Patients (CBS)

28 april 2026 bijgewerkt door: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Charles Bonnet Syndrome (CBS): Prevalence and Characteristics of Visual Hallucinations. Psychological Profile of the Visually Impaired Patient With CBS

Among patients with chronic and degenerative ocular diseases that cause visual limitations, the presence of Charles Bonnet Syndrome (CBS) may be detected as a comorbidity. CBS is as a phenomenon of complex visual hallucinations occurring in individuals with reduced visual function, in the absence of cognitive alterations, psychiatric and/or neurological conditions. It is estimated that 15.8% of patients with age-related macular degeneration and 13.5% among glaucoma patients have CBS. Prevalence rates vary widely, and this may depend on inconsistent diagnostic criteria, variability in the questions used to determine if an individual has visual hallucinations, and the reluctance of people to admit to having strange visions for fear of being considered mentally ill. Visual hallucinations can be invasive and debilitating, compromising mental health, quality of life, and rehabilitation in visually impaired individuals. Patients may experience confusion, anxiety, anger, paranoia, and social isolation. Regarding psychological aspects, about a third of patients report experiencing distress and fear,higher anxiety and social dysfunction particularly during the initial onset of symptoms and in the terminal stage of the disease.Screening questionnaires will be used.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Charles Bonnet-syndroom

Gedetailleerde beschrijving

As part of our clinical practice, screening questionnaires will be used to assess the mental health and psychological profile of enrolled patients:

PHQ-9 (Patient Health Questionnaire): A 9-question tool for screening depression, with scores ranging from 0-27 to assess depression severity. Scores above 5 require referral to a clinical psychologist; scores 15+ suggest psychiatric evaluation.

GAD-7 (General Anxiety Disorder): A 7-item tool to screen for generalized anxiety disorder, with scores from 0-21. Scores 10+ require clinical psychologist referral, and 15+ indicate the need for psychiatric evaluation.

SCL-90R (Symptom Checklist-90): A 90-item questionnaire assessing a range of psychological symptoms, including depression, anxiety, and aggression, rated on a Likert scale from 0 to 4.

NEI VFQ25 (National Eye Institute Visual Function Questionnaire): A tool to assess the quality of life related to vision.

GSES (Generalized Self-Efficacy Scale):A 10-item scale to measure perceived self-efficacy and coping mechanisms for stressful life events, rated on a 4-point Likert scale.

PSS (Perceived Stress Scale):A tool to measure how individuals perceive their life as stressful, focusing on unpredictability, uncontrollability, and overwhelm.

GHQ-12 (General Health Questionnaire-12):A 12-item questionnaire to identify general mental health problems, focusing on the past two weeks.

Studietype

Observationeel

Inschrijving (Geschat)

640

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Italië
- - Roma, Italië, 00168
    - fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Visually impaired individuals with central and peripheral defects who access the center for visual rehabilitation.

Beschrijving

Inclusion Criteria:

Best corrected visual acuity between 1/20 (1.0 LogMAR) and 3.2/10 (0.5 LogMAR) in cases of central vision impairment.
Residual binocular visual field ≤ 60% in cases of peripheral vision impairment.
Patients with age-related macular degeneration, Stargardt's disease, or glaucoma.
Age between 40 and 70 years.
Signed informed consent.

Exclusion Criteria:

Age under 40 years.
Clear cognitive impairments that reduce patient reliability.
Psychiatric disorders.
Refusal to sign informed consent to participate in the study.
Mental State Examination (MMSE) score below 22.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Prevalence of the Charles Bonnet Syndrome Tijdsspanne: From baseline through study completion, up to 24 months.	Prevalence of Charles Bonnet Syndrome, calculated as the ratio between the number of visually impaired patients affected by CBS and the total number of patients attending the visual rehabilitation center, multiplied by 100 (%).	From baseline through study completion, up to 24 months.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in Generalized Anxiety Disorder-7 (GAD-7). 7 items score. Tijdsspanne: 3 hours	Scale range: 0 to 21 Interpretation: higher scores indicate a worse outcome (greater severity of anxiety symptoms) Cut-off: greater than 5	3 hours
Change in Patient Health Questionnaire-9 (PHQ-9). 9 Items score Tijdsspanne: 3 hours	Scale range: 0 to 27 Interpretation: higher scores indicate a worse outcome (greater severity of depressive symptoms) Cut-off: greater than 5	3 hours
Change in Symptom Checklist-90 (SCL-90) . 90 items score Tijdsspanne: 3 hours	Scale range: 0 to 4 (mean score across items) Interpretation: higher scores indicate a worse outcome (greater psychological distress) Cut-off: greater than 1.5	3 hours
Change in Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). 25 items score Tijdsspanne: 3 hours	Scale range: 0 to 100 Interpretation: higher scores indicate a better outcome (better visual function and quality of life) Cut-off: less than 60	3 hours
Change in General Self-Efficacy Scale (GSES) score. Tijdsspanne: 3 hours	Scale range: 10 to 40 Interpretation: higher scores indicate a better outcome (greater perceived self-efficacy) Cut-off: less than 30	3 hours
Change in Perceived Stress Scale (PSS) score. Tijdsspanne: 3 hours	Scale range: 0 to 40 Interpretation: higher scores indicate a worse outcome (greater perceived stress) Cut-off: less than 15	3 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Onderzoekers

Hoofdonderzoeker: Stefania Fortini, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 januari 2025

Primaire voltooiing (Geschat)

31 augustus 2026

Studie voltooiing (Geschat)

31 januari 2027

Studieregistratiedata

Eerst ingediend

20 december 2024

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)