Retinal Biomarkers in Parkinson´s Disease

NCT06929026 | Active Not Recruiting

• 1 other identifier: VSN-22-129
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine whether oxygen content of the retinal vessels of the eye may serve as a biomarker in Parkinson´s disease. The main questions it aims to answer are:

1. 1.Is retinal vessel oxyhemoglobin saturation and vessel width altered in people with Parkinson´s disease?
2. 2.Is the thickness of the retinal nerve fiber layer altered in people with Parkinson´s disease?
3. 3.Is the response of ganglion cells of the inner retina and the visual cortex altered in people with Parkinson´s disease?

Conditions

Parkinson Disease

Keywords

Retinal oximetry; Pattern Electroretinography; Visual Evoked Potentials; Optical Coherence Tomography; Oxyhemoglobin saturation

Outcome Measures

Primary Outcomes (1)

• Retinal vessels oxyhemoglobin saturation

  Obtained by retinal oximetry

  Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

Secondary Outcomes (4)

• Vessel width of retinal arterioles and venules

  Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

• Retinal nerve fiber layer thickness

  Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

• Components and waveform of VEPs

  Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

• Pattern electroretinograms (PERGs)

  Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with confirmed parkinsons disease Stage 0-3 on the Hohen and Yahr scale

You may qualify if:

• Confirmed Parkinson Disease

You may not qualify if:

• Eye disease
• Diabetic Mellitus
• Chronic Obstructive Pulmonary Disease (COPD)
• Other Neurological Disease
• Smoking on a daily basis

Sponsors & Collaborators

• Landspitali University Hospital: lead
• Reykjalundur Rehabilitation: collaborator
• University of Iceland: collaborator

Study Sites (1)

Ophthalmic Outpatient Department Landspitali UH

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Thorunn S Eliasdottir, PhD, CRNA

  University Hospital of Iceland and University of Iceland. Reykjalundur

  PRINCIPAL INVESTIGATOR

• Thorunn S Eliasdottir, PhD, CRNA

  Landpitali the University Hopital of Iceland

  PRINCIPAL INVESTIGATOR

• Thorunn S Eliasdottir, PhD, CRNA

  University of Iceland

  PRINCIPAL INVESTIGATOR

• Soley Thrainsdottir, MD, PhD

  Reykjalundur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic chair, Associate Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 15, 2025
• Study Start: March 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

IC (1)