Parkinson DiseaseNCT04117555
Assessment of Pupil Light Responses in Patients With Parkinson Disease
An observational study of Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pupil response to light stimuli
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Adult, Older adult
Study population: One hundred Parkinson patients or patients with parkinsonism and 100 age-matched controls
Who may be able to join
- General inclusion criteria
- Age 30-75 years old
- Signed written informed consent
- Gender: Both (Male and Female)
- Pupillary reflex to light.
- Clear ocular media
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- 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
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Goldschleger Eye Research Institute, Sheba Medical Center,
Tel HaShomer, 52621
Lori Gueta, 972-52-7485888, Lori.Gueta@sheba.health.gov.il
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Pupil response to light stimuli
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupil response to light stimuliDiagnostic test
Objective and accurate measurement of pupillary responses to light stimuli
| Study group | Role | What they receive |
|---|---|---|
| Control | Diagnostic Test: Pupillometry Receives: Diagnostic Test: Pupil response to light stimuli | |
| Parkinson patients | Diagnostic Test: Pupillometry Receives: Diagnostic Test: Pupil response to light stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillometry
Pupil response to light stimuli
Measured: 1 day
Secondary outcomes (11)
Best corrected visual acuity
Visual Acuity
Measured: 1day
Color vision
Color vision by Farnsworth/Lanthon D-15 Test
Measured: 1 day
Humphrey 24-2 perimetry
Visual field will be assessed by Humphrey 24-2 perimetry
Measured: 1 day
Spcetral Domain Optical Coherence Tomography (SD-OCT)
Optic nerve and retinal structure will be assessed by SD-OCT
Measured: 1 day
visual evoked potential
Occipital cortex function will be assessed by visual evoked potential (VEP)
Measured: 1 day
Change from baseline Pupillometry at 1 year
Change from baseline in pupil response to light stimuli at 1 year
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Single visit: 1 day, 1 year after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start20 Nov 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Sharon Hassin, Sheba Medical Center
- Investigators
- Sharon Hassin-Baer, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117555
- Sponsor's protocol ID
- 5956-19
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pupil Light Reflex in Patients With Parkinson Disease in Comparison to Healthy Subjects.
- ClinicalTrials.gov ID
- NCT04117555
- Acronym / sponsor ID
- 5956-19
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Pupil response to light stimuliDiagnostic Test: Pupillometry |
| Parkinson patients | – | Diagnostic Test: Pupil response to light stimuliDiagnostic Test: Pupillometry |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- One hundred Parkinson patients or patients with parkinsonism and 100 age-matched controls
Key inclusion criteria (18 listed)
- General 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
- Normal eye examination
- Best-corrected visual acuity (BCVA) of 20/20
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupil response to light stimuliObjective and accurate measurement of pupillary responses to light stimuli | Diagnostic test | Control, Parkinson patients |
Primary outcome
Pupillometry
Time frame: 1 day
Pupil response to light stimuli
11 secondary outcomes
Best corrected visual acuity
Time frame: 1day
Color vision
Time frame: 1 day
Humphrey 24-2 perimetry
Time frame: 1 day
Spcetral Domain Optical Coherence Tomography (SD-OCT)
Time frame: 1 day
visual evoked potential
Time frame: 1 day
Change from baseline Pupillometry at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Change from baseline best corrected visual acuity at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Change from baseline color vision at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Change from baseline Humphrey 24-2 at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Change from baseline SD-OCT at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Change from baseline visual evoked potential at 1 year
Time frame: Single visit: 1 day, 1 year after baseline testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Hassin-Baer, Prof. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori Gueta (972527485888, Lori.Gueta@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillometry (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.