Prevalence, Psychiatrist InterventionCBSNCT03148249
A Trial of Patients With a Charles Bonnet Syndrome
A study testing interview in people with Prevalence, Psychiatrist Intervention, run by Vienna Institute for Research in Ocular Surgery.
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. Read more about this study
- Who is it for?
- Ages 55 to 105 years
- Conditions the study is for
- Prevalence, Psychiatrist Intervention
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2014to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- 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
About this study
Official title: A Randomized Control 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.
Read the 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.
- Conditions
- Prevalence, Psychiatrist Intervention
- Being tested
- interview
- Keywords
- Randomized control trial, Charles Bonnet syndrome, visual hallucinations, age related macular degeneration, patient education
- Medical subject headings
- Charles Bonnet Syndrome, Hallucinations, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
control group: interview, study group: explanation and exploration
| Study group | Role | What they receive |
|---|---|---|
| interview with an ophthalmologist | Experimental | Patients get an interview with an ophthalmologist Receives: Other: interview |
| interview/treatment by a psychiatrist | Experimental | patients get an interview and a possible treatment by a psychiatrist Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score between the two groups
Quality of life score between the study and control group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start10 Oct 2014
- Primary completion17 Feb 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence, Psychiatrist InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148249
- Sponsor's protocol ID
- VIROS
- Acronym
- CBS
- Status last verified
- Jun 2017
- First submitted
- 9 Feb 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Patients With a Charles Bonnet Syndrome
- ClinicalTrials.gov ID
- NCT03148249
- Acronym / sponsor ID
- CBS / VIROS
- Conditions
- Prevalence, Psychiatrist Intervention
- Keywords
- Randomized control trial, Charles Bonnet syndrome, visual hallucinations, age related macular degeneration, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 10 Oct 2014 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interview with an ophthalmologist | Experimental | Other: interviewPatients get an interview with an ophthalmologist |
| interview/treatment by a psychiatrist | Experimental | Other: interviewpatients get an interview and a possible treatment by a psychiatrist |
Who may qualify
- Ages
- 55 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- written informed consent
- visual acuity of 0.5 LogMAR or less at both eyes
- 55 years or older
- have no mental pathologies such as dementia, psychosis or any other neurological diseases
- have a normal cognitive state
Key exclusion criteria (8 listed)
- dopamine agonist medication
- temporal lobe epilepsy
- moderate to severe Alzheimer's dementia
- present chronic alcohol-/drug abuse
- bad cognitive state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewcontrol group: interview, study group: explanation and exploration | Other | interview with an ophthalmologist, interview/treatment by a psychiatrist |
Primary outcome
Quality of life score between the two groups
Time frame: 3 months
Quality of life score between the study and control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Prevalence, Psychiatrist Intervention, run by Vienna Institute for Research in Ocular Surgery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score between the two groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.