NCT04117555招募中不适用
Assessment of Pupil Light Reflex in Patients With Parkinson Disease in Comparison to Healthy Subjects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pupillometry
研究概览
简要总结
Parkinson diseases (PD) is the second most common degenerative disease of the central nervous system. The development of early diagnostic biomarkers may help identify at-risk individuals and allow precocious interventions at the onset of disease and more precise monitoring of therapies that may slow disease progression.
Proof of concept studies indicated significant differences in pupil light response between PD patients and healthy controls. The feasibility of using pupillometry for assesment of PD will be examined.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria
- •Age 30-75 years old
- •Signed written informed consent
- •Gender: Both (Male and Female)
- •Pupillary reflex to light.
- •Clear ocular media
- •Patients' Inclusion Criteria:
- •Patients with clinical presentations of the neurodegenerative forms of parkinsonism (bradykinesia, extrapyramidal rigidity, tremor, postural instability and gait disturbance) including: idiopathic Parkinson disease (PD), Lewy body disease (LBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD) and secondary parkinsonisms.
- •Control group- inclusion criteria
- •Normal eye examination
- •Best-corrected visual acuity (BCVA) of 20/20
- •Normal color vision test (Farnsworth/Lanthon D-15 Test)
- •No present ocular disease
- •No past ocular disease or surgery within last 6 months
- •No use of any topical or systemic medications that could adversely influence efferent pupil movements
- •Normal 24-2 Humphrey visual field and
- •Short duration (≤10 minutes)
- •Minimal fixation losses, False positive errors and False negative errors (less than 30% for each one of reliability indices)
排除标准
- •Diagnosis of dementia.
- •Cognitive decline that may impair obtaining informed consent.
- •Tremor or dyskinesia that could interfere with ophthalmic evaluation
- •History of past (last 3 months) or present ocular disease or ocular surgery
- •Use of any topical or systemic medications that could adversely influence pupillary reflex
- •Psychiatric illness, active psychosis.
- •Previous neurosurgical interventions, including stereotactic neurosurgical procedures.
- •Past or current strokes or brain injury and other brain disorders (except PD/parkinsonism for patient group)
- •Anti-dopaminergic drugs.
- •Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tomometry or other schedule study procedure.
- •Visual media opacity including cloudy corneas.
- •Any condition preventing accurate measurement or examination of the pupil.
结局指标
主要结局
Pupillometry
时间窗: 1 day
Pupil response to light stimuli
次要结局
- Humphrey 24-2 perimetry(1 day)
- Color vision(1 day)
- Change from baseline best corrected visual acuity at 1 year(Single visit: 1 day, 1 year after baseline testing)
- Best corrected visual acuity(1day)
- Change from baseline color vision at 1 year(Single visit: 1 day, 1 year after baseline testing)
- Change from baseline SD-OCT at 1 year(Single visit: 1 day, 1 year after baseline testing)
- visual evoked potential(1 day)
- Change from baseline visual evoked potential at 1 year(Single visit: 1 day, 1 year after baseline testing)
- Spcetral Domain Optical Coherence Tomography (SD-OCT)(1 day)
- Change from baseline Pupillometry at 1 year(Single visit: 1 day, 1 year after baseline testing)
- Change from baseline Humphrey 24-2 at 1 year(Single visit: 1 day, 1 year after baseline testing)
研究者
Dr. Sharon Hassin
Prof.
Sheba Medical Center
研究点 (1)
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