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Search / Trial NCT04117555

Assessment of Pupil Light Responses in Patients With Parkinson Disease

Launched by SHEBA MEDICAL CENTER · Oct 3, 2019

Trial Information

Current as of June 10, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how the pupils (the black part in the center of the eye) respond to light in patients with Parkinson's Disease (PD) compared to healthy individuals. Researchers believe that measuring these responses could help identify people who are at risk for developing PD earlier and monitor how well treatments are working. The study aims to explore if this method, called pupillometry, is a practical way to assess the disease.

To participate in this trial, you must be between 30 and 75 years old and be able to give consent. You could be eligible if you have been diagnosed with various forms of parkinsonism, such as idiopathic Parkinson's disease or progressive supranuclear palsy, or if you are a healthy individual with normal eye health. Participants can expect to undergo simple eye examinations that will take about 10 minutes. It's important to note that people with certain conditions, like dementia or recent eye surgeries, cannot take part in the study. This research could lead to better ways to detect and manage Parkinson's Disease in the future.

Gender

ALL

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.

About Sheba Medical Center

Sheba Medical Center, located in Israel, is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, Sheba Medical Center leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and developing novel therapeutic interventions. The center's collaborative environment fosters partnerships with global research organizations, enhancing its ability to contribute to the scientific community and drive medical advancements across various fields. With a strong focus on patient safety and ethical standards, Sheba Medical Center is dedicated to translating research findings into practical applications that benefit patients worldwide.

Locations

Tel Hashomer, , Israel

Patients applied

0 patients applied

Trial Officials

Sharon Hassin-Baer, Prof.

Principal Investigator

Sheba Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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