Assessment of Pupil Light Responses in Patients With Parkinson Disease

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Pupil Light Reflex in Patients With Parkinson Disease in Comparison to Healthy Subjects.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Diagnostic Test: Pupil response to light stimuli


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Diagnostic Test: Pupillometry | Diagnostic Test: Pupil response to light stimuli<br>* Objective and accurate measurement of pupillary responses to light stimuli<br>|
| Parkinson patients<br>Diagnostic Test: Pupillometry | Diagnostic Test: Pupil response to light stimuli<br>* Objective and accurate measurement of pupillary responses to light stimuli<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupillometry | Pupil response to light stimuli | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Visual Acuity | 1day | 
| Color vision | Color vision by Farnsworth/Lanthon D-15 Test | 1 day | 
| Humphrey 24-2 perimetry | Visual field will be assessed by Humphrey 24-2 perimetry | 1 day | 
| Spcetral Domain Optical Coherence Tomography (SD-OCT) | Optic nerve and retinal structure will be assessed by SD-OCT | 1 day | 
| visual evoked potential | Occipital cortex function will be assessed by visual evoked potential (VEP) | 1 day | 
| Change from baseline Pupillometry at 1 year | Change from baseline in pupil response to light stimuli at 1 year | Single visit: 1 day, 1 year after baseline testing | 
| Change from baseline best corrected visual acuity at 1 year | Change from baseline visual acuity at 1 year | Single visit: 1 day, 1 year after baseline testing | 
| Change from baseline color vision at 1 year | Change from baseline color vision by Farnsworth/Lanthon D-15 at 1 year | Single visit: 1 day, 1 year after baseline testing | 
| Change from baseline Humphrey 24-2 at 1 year | Change from baseline Humphrey 24-2 visual field at 1 year | Single visit: 1 day, 1 year after baseline testing | 
| Change from baseline SD-OCT at 1 year | Change from baseline optic nerve and retinal structure by SD-OCTat 1 year | Single visit: 1 day, 1 year after baseline testing | 
| Change from baseline visual evoked potential at 1 year | Change from baseline occipital cortex function by visual evoked potential testing to at 1 year | Single visit: 1 day, 1 year after baseline testing |