A Trial of Patients With a Charles Bonnet Syndrome

NCT03148249 | Completed

• 1 other identifier: VIROS
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

Charles Bonnet Syndrome (CBS) is defined by the occurence of visual hallucinations (VH) in the absence of any mental disorder. Elderly patients with reduced visual acuity due to ophthalmic diseases are most affected. Conditions are often associated with the syndrome of age-related macular degeneration, cataract or glaucoma. Existing data on the syndrome's prevalence in Europe reveal diverse results. Aim of this study was to assess the prevalence of CBS in patients with low visual acuity and to evaluate, if an additional therapeutic interview with and treatment by a psychiatrist is beneficial.

Conditions

Prevalence, Psychiatrist Intervention

Keywords

Randomized control trial; Charles Bonnet syndrome; visual hallucinations; age related macular degeneration; patient education

Outcome Measures

Primary Outcomes (1)

• Quality of life score between the two groups

  Quality of life score between the study and control group

  3 months

Study Arms (2)

interview with an ophthalmologist

EXPERIMENTAL

Patients get an interview with an ophthalmologist

Other: interview

interview/treatment by a psychiatrist

EXPERIMENTAL

patients get an interview and a possible treatment by a psychiatrist

Other: interview

Interventions

interview OTHER

control group: interview, study group: explanation and exploration

interview with an ophthalmologist; interview/treatment by a psychiatrist

Eligibility Criteria

• Age: 55 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• visual acuity of 0.5 LogMAR or less at both eyes
• years or older
• Patients with CBS:
• have no mental pathologies such as dementia, psychosis or any other neurological diseases
• have a normal cognitive state
• are not able to control the VH
• know that the VH are not real
• are usually older
• have significantly reduced visual acuity due to an bilateral eye pathology
• VH associated with CBS:
• disappear when the eyes are closed
• are repetitive
• are complex (eg. objects, geometrical patterns, faces, shapes, figures, scenes, animals or plants)

You may not qualify if:

• dopamine agonist medication
• temporal lobe epilepsy
• moderate to severe Alzheimer's dementia
• present chronic alcohol-/drug abuse
• bad cognitive state
• There are no:
• auditory or olfactory hallucinations
• other abnormalities like delusions

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

MeSH Terms

Conditions

Charles Bonnet Syndrome; Hallucinations; Macular Degeneration

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr., MBA

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: May 10, 2017
• Study Start: October 10, 2014
• Primary Completion: February 17, 2016
• Study Completion: February 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share