Clinical trial NCT04117555: Assessment of Pupil Light Responses in Patients With Parkinson Disease
Official title: Assessment of Pupil Light Reflex in Patients With Parkinson Disease in Comparison to Healthy Subjects.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred Parkinson patients or patients with parkinsonism and 100 age-matched controls

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pupillometry
timeFrame: 1 day
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 1day
measure: Color vision
timeFrame: 1 day
measure: Humphrey 24-2 perimetry
timeFrame: 1 day
measure: Spcetral Domain Optical Coherence Tomography (SD-OCT)
timeFrame: 1 day
measure: visual evoked potential
timeFrame: 1 day
measure: Change from baseline Pupillometry at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
measure: Change from baseline best corrected visual acuity at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
measure: Change from baseline color vision at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
measure: Change from baseline Humphrey 24-2 at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
measure: Change from baseline SD-OCT at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
measure: Change from baseline visual evoked potential at 1 year
timeFrame: Single visit: 1 day, 1 year after baseline testing
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Goldschleger Eye Research Institute, Sheba Medical Center,
Study officials:
affiliation: Sheba Medical Center
name: Sharon Hassin-Baer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: