Assessment of Pupil Light Responses in Patients With Parkinson Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: Pupil response to light stimuli

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lori Gueta; Phone Number: 972527485888; Email: Lori.Gueta@sheba.health.gov.il

Study Locations

• Israel
  • Tel HaShomer, Israel, 52621
    • Recruiting
    • Goldschleger Eye Research Institute, Sheba Medical Center,
    • Contact: Lori Gueta; Phone Number: 972-52-7485888; Email: Lori.Gueta@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

One hundred Parkinson patients or patients with parkinsonism and 100 age-matched controls

Description

Inclusion Criteria:

• General inclusion criteria

  1. Age 30-75 years old
  2. Signed written informed consent
  3. Gender: Both (Male and Female)
  4. Pupillary reflex to light.
  5. 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

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:

1. Diagnosis of dementia.
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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Diagnostic Test: Pupillometry	Diagnostic test: Pupil response to light stimuli; Objective and accurate measurement of pupillary responses to light stimuli
Parkinson patients; Diagnostic Test: Pupillometry	Diagnostic test: Pupil response to light stimuli; Objective and accurate measurement of pupillary responses to light stimuli

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Sharon Hassin-Baer, Prof., Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 5956-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No