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Charles Bonnet Syndrome in Low Vision Patients (CBS)

2026년 4월 28일 업데이트: 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.

연구 개요

상태

초대로 등록

정황

찰스 보닛 증후군

상세 설명

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.

연구 유형

관찰

등록 (추정된)

640

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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해당 없음

샘플링 방법

확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Prevalence of the Charles Bonnet Syndrome 기간: 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.

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

수사관

수석 연구원: Stefania Fortini, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 15일

기본 완료 (추정된)

2026년 8월 31일

연구 완료 (추정된)

2027년 1월 31일

연구 등록 날짜

최초 제출

2024년 12월 20일

QC 기준을 충족하는 최초 제출

2026년 4월 28일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)