Charles Bonnet Syndrome in Low Vision Patients

NCT07563101 | Enrolling By Invitation

• 1 other identifier: ID 6502
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Charles Bonnet Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of the Charles Bonnet Syndrome

  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.

Secondary Outcomes (6)

• Change in Generalized Anxiety Disorder-7 (GAD-7). 7 items score.

  3 hours

• Change in Patient Health Questionnaire-9 (PHQ-9). 9 Items score

  3 hours

• Change in Symptom Checklist-90 (SCL-90) . 90 items score

  3 hours

• Change in Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). 25 items score

  3 hours

• Change in General Self-Efficacy Scale (GSES) score.

  3 hours

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Charles Bonnet Syndrome

Condition Hierarchy (Ancestors)

Hallucinations; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefania Fortini, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: May 1, 2026
• Study Start: January 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-12

Locations

IT (1)