Assessment of Pupil Light Responses in Patients With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117555
• Other study ID #: 5956-19
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: Lori Gueta
• Phone: 972527485888
• Email: Lori.Gueta[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• Pupil response to light stimuli
Objective and accurate measurement of pupillary responses to light stimuli

Locations

Country	Name	City	State
Israel	Goldschleger Eye Research Institute, Sheba Medical Center,	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupillometry	Pupil response to light stimuli	1 day
Secondary	Best corrected visual acuity	Visual Acuity	1day
Secondary	Color vision	Color vision by Farnsworth/Lanthon D-15 Test	1 day
Secondary	Humphrey 24-2 perimetry	Visual field will be assessed by Humphrey 24-2 perimetry	1 day
Secondary	Spcetral Domain Optical Coherence Tomography (SD-OCT)	Optic nerve and retinal structure will be assessed by SD-OCT	1 day
Secondary	visual evoked potential	Occipital cortex function will be assessed by visual evoked potential (VEP)	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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