A Trial of Patients With a Charles Bonnet Syndrome

Prevalence, Psychiatrist Intervention Clinical Trial

— CBS  

Official title:

A Randomized Control Trial of Patients With a Charles Bonnet Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148249
• Other study ID #: VIROS
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: June 26, 2017
• Start date: October 10, 2014
• Est. completion date: February 1, 2017

Study information

• Verified date: June 2017
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with a visual acuity of 0.5 LogMAR or less in the better eye were screened for CBS. Instruments used were an interview asking for details of the hallucinations, a mental test and a scale concerning quality of life. Patients with CBS were randomized by minimization in two groups: in group 1, a patient-doctor interview by an ophthalmologist was performed and in group 2 an interview and if needed, a therapy by a psychiatrist. At the 3-months follow up, the psychological strain of patients was recorded again.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 1, 2017
• Est. primary completion date: February 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 105 Years

Eligibility

Inclusion Criteria:

• written informed consent

• visual acuity of 0.5 LogMAR or less at both eyes

• 55 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prevalence, Psychiatrist Intervention

Intervention

Other:
• interview
control group: interview, study group: explanation and exploration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life score between the two groups	Quality of life score between the study and control group	3 months