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

Sheba Medical Center1 site in 1 country200 target enrollmentNovember 20, 2019

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Sheba Medical Center
Enrollment: 200
Locations: 1
Primary Endpoint: Pupillometry
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2019

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sheba Medical Center

Responsible Party

Principal Investigator

Dr. Sharon Hassin

Prof.

Sheba Medical Center

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Pupillometry

Time Frame: 1 day

Pupil response to light stimuli

Secondary Outcomes

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)