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Enrolling by invitation Observational

Charles Bonnet Syndrome in Low Vision Patients

NCT07563101 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-15
Last updated
2026-05-01

Condition(s) studied

Charles Bonnet Syndrome

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Prevalence of the Charles Bonnet Syndrome — 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 (%).

Trial sites (1)

FacilityCityRegionStatus
fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione Roma Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563101 on ClinicalTrials.gov ↗ ← All trials in Italy