NCT04117555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

5.1 years

First QC Date

September 18, 2019

Last Update Submit

November 21, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Pupillometry

    Pupil response to light stimuli

    1 day

Secondary Outcomes (11)

  • Best corrected visual acuity

    1day

  • Color vision

    1 day

  • Humphrey 24-2 perimetry

    1 day

  • Spcetral Domain Optical Coherence Tomography (SD-OCT)

    1 day

  • visual evoked potential

    1 day

  • +6 more secondary outcomes

Study Arms (2)

Control

Diagnostic Test: Pupillometry

Diagnostic Test: Pupil response to light stimuli

Parkinson patients

Diagnostic Test: Pupillometry

Diagnostic Test: Pupil response to light stimuli

Interventions

Pupil response to light stimuliDIAGNOSTIC_TEST

Objective and accurate measurement of pupillary responses to light stimuli

ControlParkinson patients

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 30-75 years old
  • Signed written informed consent
  • Gender: Both (Male and Female)
  • Pupillary reflex to light.
  • 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.
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldschleger Eye Research Institute, Sheba Medical Center,

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sharon Hassin-Baer, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori Gueta

CONTACT

972527485888Lori.Gueta@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 18, 2019

First Posted

October 7, 2019

Study Start

November 20, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)