Validation of Bulbicam for Use on Patient Suffering From Parkinson and Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Meddoc
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Saccade
研究概览
简要总结
Aim is to investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering Parkinson (PD),Ataxia (AT) and matched healthy control (HC).
Study population The study consists of the patients suffering from PD or AT and HV of both genders above 18 years of age without any eye- or neurological disorder.
Bulbicam will be used in the study and five tests will be performed
The study will be performed as a controlled, open and non-randomized, stratified observational single center. The stratification factors will be pathology (PD&AT) and internal classifications. ed.
The main variables will be the variables recorded at the four Bulbicam tests and the standard neuro-ophthalmological variables included for PD and AT
Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. During the first day of the study, the included patients will undergo a neuro-ophthalmological examination by a neurologist. Additionally, Bulbicam examination will be performed twice with a rest period of one hour between each registration.
The healthy controls will only undergo a standard examination and twice BulbiCam examination. The controls will only participate one day. The patients will participate two more days with two Bulbicam examinations per day.
Sample size:
Sixteen PD-patients ,16 AT-patients and 32 HCs will be included in the study.
详细描述
Aim
- To investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering from PD, AT and HC.
- To contribute to establishment of normal range for PD and AT patients with different degree in the disease development related to the Bulbicam tests.
- To contribute to establishment of normal range of these Bulbicam tests for a normal population without neurological or ophthalmological disease.
Study population The study consists of the following three study populations: 1) Patients suffering from PD of both genders above 18 years of age; 2) Patients suffering from AT of both genders above 18 years of age; 3) Gender- and age-matched HC without any eye- or neurological disorder.
Trial equipment Bulbicam will be used in the study and the following five tests will be performed at each investigation: "Fixation", "Saccade" "Nystagmus", "Smooth pursuit" and "Pupil".
Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with either PD or AT of both gender; at least the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.
- •gender- and age-matched controls to patients ; passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.
排除标准
- •Other visual disturbances and blindness
- •Posterior Chamber Intraocular Lens (PCIOL)
- •Physical or psychiatric disease, which may disturb the measuring procedure
- •Paresis or paralysis of any oculomotor muscle
- •Patients whose visual acuity is less than 0.1 in any eye, as these will not be able to focus on the test stimuli.
- •Patients whose visible part of the eye is abnormal, such as subconjunctival haemorrhages or deformed pupils
- •Patients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.
- •With known alcoholic and drug dependency
- •Not able to understand information.
- •Not willing to give written consent to participate in the study.
结局指标
主要结局
Saccade
时间窗: 37 hours
Latency in ms
Pupil
时间窗: 37 hours
Diameter in mm
Nystagmus
时间窗: 37 hours
Frequency in Hz
Fixation
时间窗: 37 hours
Stability in mm
Smooth pursuit 1
时间窗: 37 hours
Gain velocity in degree
次要结局
未报告次要终点