A Randomized Control Trial of Patients With a Charles Bonnet Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- Quality of life score between the two groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Quality of life score between the two groups
时间窗: 3 months
Quality of life score between the study and control group
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Univ. Prof. Dr., MBA
Vienna Institute for Research in Ocular Surgery