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Charles Bonnet Syndrome in Low Vision Patients (CBS)

28. april 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Charles Bonnets syndrom

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

640

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Prevalence of the Charles Bonnet Syndrome Tidsramme: 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.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in Generalized Anxiety Disorder-7 (GAD-7). 7 items score. Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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. Tidsramme: 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. Tidsramme: 3 hours	Scale range: 0 to 40 Interpretation: higher scores indicate a worse outcome (greater perceived stress) Cut-off: less than 15	3 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. januar 2025

Primær fullføring (Antatt)

31. august 2026

Studiet fullført (Antatt)

31. januar 2027

Datoer for studieregistrering

Først innsendt

20. desember 2024

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)