Assessment of Pupil Light Responses in Patients With Parkinson Disease
NCT ID: NCT04117555
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-11-20
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control
Diagnostic Test: Pupillometry
Pupil response to light stimuli
Objective and accurate measurement of pupillary responses to light stimuli
Parkinson patients
Diagnostic Test: Pupillometry
Pupil response to light stimuli
Objective and accurate measurement of pupillary responses to light stimuli
Interventions
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Pupil response to light stimuli
Objective and accurate measurement of pupillary responses to light stimuli
Eligibility Criteria
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Inclusion Criteria
2. Signed written informed consent
3. Gender: Both (Male and Female)
4. Pupillary reflex to light.
5. Clear ocular media
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.
1. Normal eye examination
2. Best-corrected visual acuity (BCVA) of 20/20
3. Normal color vision test (Farnsworth/Lanthon D-15 Test)
4. No present ocular disease
5. No past ocular disease or surgery within last 6 months
6. No use of any topical or systemic medications that could adversely influence efferent pupil movements
7. 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
2. Cognitive decline that may impair obtaining informed consent.
3. Tremor or dyskinesia that could interfere with ophthalmic evaluation
4. History of past (last 3 months) or present ocular disease or ocular surgery
5. Use of any topical or systemic medications that could adversely influence pupillary reflex
6. Psychiatric illness, active psychosis.
7. Previous neurosurgical interventions, including stereotactic neurosurgical procedures.
8. Past or current strokes or brain injury and other brain disorders (except PD/parkinsonism for patient group)
9. Anti-dopaminergic drugs.
10. Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tomometry or other schedule study procedure.
11. Visual media opacity including cloudy corneas.
12. Any condition preventing accurate measurement or examination of the pupil.
30 Years
75 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Sharon Hassin
Prof.
Principal Investigators
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Sharon Hassin-Baer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Goldschleger Eye Research Institute, Sheba Medical Center,
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5956-19
Identifier Type: -
Identifier Source: org_study_id