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A Trial of Patients With a Charles Bonnet Syndrome (CBS)

Primary Purpose

Prevalence, Psychiatrist Intervention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interview
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prevalence, Psychiatrist Intervention focused on measuring Randomized control trial, Charles Bonnet syndrome, visual hallucinations, age related macular degeneration, patient education

Eligibility Criteria

55 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    interview with an ophthalmologist

    interview/treatment by a psychiatrist

    Arm Description

    Patients get an interview with an ophthalmologist

    patients get an interview and a possible treatment by a psychiatrist

    Outcomes

    Primary Outcome Measures

    Quality of life score between the two groups
    Quality of life score between the study and control group

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2017
    Last Updated
    June 26, 2017
    Sponsor
    Vienna Institute for Research in Ocular Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03148249
    Brief Title
    A Trial of Patients With a Charles Bonnet Syndrome
    Acronym
    CBS
    Official Title
    A Randomized Control Trial of Patients With a Charles Bonnet Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2014 (Actual)
    Primary Completion Date
    February 17, 2016 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vienna Institute for Research in Ocular Surgery

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prevalence, Psychiatrist Intervention
    Keywords
    Randomized control trial, Charles Bonnet syndrome, visual hallucinations, age related macular degeneration, patient education

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    interview with an ophthalmologist
    Arm Type
    Experimental
    Arm Description
    Patients get an interview with an ophthalmologist
    Arm Title
    interview/treatment by a psychiatrist
    Arm Type
    Experimental
    Arm Description
    patients get an interview and a possible treatment by a psychiatrist
    Intervention Type
    Other
    Intervention Name(s)
    interview
    Intervention Description
    control group: interview, study group: explanation and exploration
    Primary Outcome Measure Information:
    Title
    Quality of life score between the two groups
    Description
    Quality of life score between the study and control group
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    105 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Trial of Patients With a Charles Bonnet Syndrome

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