Assessment of Pupil Light Responses in Patients With Parkinson Disease

Recruiting

• Conditions: Parkinson Disease
• Interventions: Diagnostic Test: Pupil response to light stimuli

• Registration Number: NCT04117555
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Study Start: 2019-11-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson patients	Pupil response to light stimuli	Diagnostic Test: Pupillometry
Control	Pupil response to light stimuli	Diagnostic Test: Pupillometry

Primary Outcome Measures

Name	Time	Method
Pupillometry	1 day	Pupil response to light stimuli

Secondary Outcome Measures

Name	Time	Method
Humphrey 24-2 perimetry	1 day	Visual field will be assessed by Humphrey 24-2 perimetry
Color vision	1 day	Color vision by Farnsworth/Lanthon D-15 Test
Change from baseline best corrected visual acuity at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline visual acuity at 1 year
Best corrected visual acuity	1day	Visual Acuity
Change from baseline color vision at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline color vision by Farnsworth/Lanthon D-15 at 1 year
Change from baseline SD-OCT at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline optic nerve and retinal structure by SD-OCTat 1 year
visual evoked potential	1 day	Occipital cortex function will be assessed by visual evoked potential (VEP)
Change from baseline visual evoked potential at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline occipital cortex function by visual evoked potential testing to at 1 year
Spcetral Domain Optical Coherence Tomography (SD-OCT)	1 day	Optic nerve and retinal structure will be assessed by SD-OCT
Change from baseline Pupillometry at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline in pupil response to light stimuli at 1 year
Change from baseline Humphrey 24-2 at 1 year	Single visit: 1 day, 1 year after baseline testing	Change from baseline Humphrey 24-2 visual field at 1 year

Trial Locations

Locations (1)

Goldschleger Eye Research Institute, Sheba Medical Center,; 🇮🇱 Tel HaShomer, Israel