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Completed

NCT Number: NCT03148249

A Trial of Patients With a Charles Bonnet Syndrome

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.

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Key information

Conditions

Prevalence, Psychiatrist Intervention Charles Bonnet Syndrome Eye Diseases Hallucinations Macular Degeneration Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Retinal Degeneration Retinal Diseases Signs and Symptoms

Age range

55 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

control group: interview, study group: explanation and exploration

Primary outcomes

  1. Quality of life score between the two groups

    Time frame: 3 months

    Quality of life score between the study and control group

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

A Randomized Control Trial of Patients With a Charles Bonnet Syndrome

Acronym: CBS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 10, 2017
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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