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Active, Not Recruiting

NCT Number: NCT06929026

Retinal Biomarkers in Parkinson´s Disease

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

The study procedure is threefold. The participants will:

A. Sit in front of a screen and focus on a red dot of its middle. A simple recording electrodes are applied on the cornea, forehead and scalp for the electrophysiological measurements. Prior to this procedure a topical anesthetic gel is applied to numb the eye to prevent discomfort from placement of the corneal electrodes.

B. Undergo general eye examination and optical coherence tomography (OCT) to measure the retinal tissue thickness. Prior to eye examination,eye drops are applied into the eyes to enlarge the pupils C. Sit in front of a fundus camera for obtaining images of the retinal vessels to measure oxygen saturation and the vessel width

Researchers will compare the obtained measurements with age- and gender matching of healthy controls.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmic Outpatient Department Landspitali UH

Reykjavik, 101, Iceland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed Parkinson Disease

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Retinal vessels oxyhemoglobin saturation

    Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

    Obtained by retinal oximetry

Secondary outcomes

  1. Vessel width of retinal arterioles and venules

    Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

    Obtained by retinal oximetry

  2. Retinal nerve fiber layer thickness

    Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

    Obtained by cross-sectional imaging of the retinal tissue (OCT)

  3. Components and waveform of VEPs

    Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

    Pattern electroretinogram (PERG)

  4. Pattern electroretinograms (PERGs)

    Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali

    Amplitude of the visual evoked potential response

Sponsors and collaborators

Lead sponsor

Landspitali University Hospital

Other

Collaborators

  • Reykjalundur Rehabilitation
  • University of Iceland

Registry information

Official study title

Retinal Biomarkers in Parkinson´s Disease: Retinal Oximetry, Pattern Electroretinography (PERG), Visual Evoked Potentials (VEP) and Optical Coherence Tomography (OCT)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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