ClinicalTrials.gg
Active, not recruitingNCT06929026Updated Apr 15, 2025

Retinal Biomarkers in Parkinson´s Disease

An observational study in Parkinson Disease, sponsored by Landspitali University Hospital. Active, not recruiting at 1 site in Iceland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Landspitali University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Parkinson Disease

Browse trials for

Keywords

  • Retinal oximetry
  • Pattern Electroretinography
  • Visual Evoked Potentials
  • Optical Coherence Tomography
  • Oxyhemoglobin saturation
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's planned enrollment of 60 is below the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Landspitali University Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed Parkinson Disease

Exclusion criteria

Exclusion Criteria:

  • Eye disease
  • Diabetic Mellitus
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Other Neurological Disease
  • Smoking on a daily basis
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Retinal vessels oxyhemoglobin saturation

    Obtained by retinal oximetry

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

Secondary outcomes

  1. Vessel width of retinal arterioles and venules

    Obtained by retinal oximetry

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

  2. Retinal nerve fiber layer thickness

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

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

  3. Components and waveform of VEPs

    Pattern electroretinogram (PERG)

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

  4. Pattern electroretinograms (PERGs)

    Amplitude of the visual evoked potential response

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

07

Study locations

1 site
  • Ophthalmic Outpatient Department Landspitali UH
    Reykjavik, 101, Iceland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2025
First posted
Apr 15, 2025
StartActual
Mar 10, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06929026
Lead sponsor
Landspitali University Hospital
Collaborators
Reykjalundur Rehabilitation, University of Iceland
Responsible party
Thorunn Scheving Eliasdottir (Academic chair, Associate Professor, Landspitali University Hospital) — Principal investigator
First posted
Apr 15, 2025
Start date
Mar 10, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 15, 2025

Study contacts

Thorunn S Eliasdottir, PhD, CRNA
principal investigator · University Hospital of Iceland and University of Iceland. Reykjalundur
Thorunn S Eliasdottir, PhD, CRNA
principal investigator · Landpitali the University Hopital of Iceland
Thorunn S Eliasdottir, PhD, CRNA
principal investigator · University of Iceland
Soley Thrainsdottir, MD, PhD
principal investigator · Reykjalundur

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion