A Trial of Patients With a Charles Bonnet Syndrome (NCT03148249) | Clinical Trial Compass
CompletedNot Applicable
A Trial of Patients With a Charles Bonnet Syndrome
34 participantsStarted 2014-10-10
Plain-language 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.
Who can participate
Age range
55 Years – 105 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life score between the two groups
Timeframe: 3 months
Trial details
NCT IDNCT03148249
SponsorVienna Institute for Research in Ocular Surgery