Parkinson DiseaseNCT06929026
Retinal Biomarkers in Parkinson´s Disease
An observational study of Parkinson Disease, run by Landspitali University Hospital at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 60 participants
- Where
- 1 siteIceland
- Study dates
- 10 Mar 2023to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with confirmed parkinsons disease Stage 0-3 on the Hohen and Yahr scale
Who may be able to join
- Confirmed Parkinson Disease
Who cannot join
- Eye disease
- Diabetic Mellitus
- Chronic Obstructive Pulmonary Disease (COPD)
- Other Neurological Disease
- Smoking on a daily basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Biomarkers in Parkinson´s Disease: Retinal Oximetry, Pattern Electroretinography (PERG), Visual Evoked Potentials (VEP) and Optical Coherence Tomography (OCT)
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:
- Is retinal vessel oxyhemoglobin saturation and vessel width altered in people with Parkinson´s disease?
- Is the thickness of the retinal nerve fiber layer altered in people with Parkinson´s disease?
- Is the response of ganglion cells of the inner retina and the visual cortex altered in people with Parkinson´s disease?
Read more
The study procedure is threefold. The participants will:
- 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.
- 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.
- Conditions
- Parkinson Disease
- Keywords
- Retinal oximetry, Pattern Electroretinography, Visual Evoked Potentials, Optical Coherence Tomography, Oxyhemoglobin saturation
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessels oxyhemoglobin saturation
Obtained by retinal oximetry
Measured: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Secondary outcomes (4)
Vessel width of retinal arterioles and venules
Obtained by retinal oximetry
Measured: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Retinal nerve fiber layer thickness
Obtained by cross-sectional imaging of the retinal tissue (OCT)
Measured: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Components and waveform of VEPs
Pattern electroretinogram (PERG)
Measured: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Pattern electroretinograms (PERGs)
Amplitude of the visual evoked potential response
Measured: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Reykjalundur Rehabilitation, University of Iceland
- Responsible party
- Principal investigator, Thorunn Scheving Eliasdottir, Landspitali University Hospital
- Investigators
- Thorunn S Eliasdottir, PhD, CRNA, Principal investigator, University Hospital of Iceland and University of Iceland. ReykjalundurThorunn S Eliasdottir, PhD, CRNA, Principal investigator, Landpitali the University Hopital of IcelandThorunn S Eliasdottir, PhD, CRNA, Principal investigator, University of IcelandSoley Thrainsdottir, MD, PhD, Principal investigator, Reykjalundur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929026
- Sponsor's protocol ID
- VSN-22-129
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Biomarkers in Parkinson´s Disease: Retinal Oximetry, Pattern Electroretinography (PERG), Visual Evoked Potentials (VEP) and Optical Coherence Tomography (OCT)
- ClinicalTrials.gov ID
- NCT06929026
- Acronym / sponsor ID
- VSN-22-129
- Conditions
- Parkinson Disease
- Keywords
- Retinal oximetry, Pattern Electroretinography, Visual Evoked Potentials, Optical Coherence Tomography, Oxyhemoglobin saturation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- Reykjalundur Rehabilitation, University of Iceland
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2025 (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.
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:
- Is retinal vessel oxyhemoglobin saturation and vessel width altered in people with Parkinson´s disease?
- Is the thickness of the retinal nerve fiber layer altered in people with Parkinson´s disease?
- 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:
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with confirmed parkinsons disease Stage 0-3 on the Hohen and Yahr scale
Key inclusion criteria (1 listed)
- Confirmed Parkinson Disease
Key exclusion criteria (5 listed)
- Eye disease
- Diabetic Mellitus
- Chronic Obstructive Pulmonary Disease (COPD)
- Other Neurological Disease
- Smoking on a daily basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal vessels oxyhemoglobin saturation
Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Obtained by retinal oximetry
4 secondary outcomes
Vessel width of retinal arterioles and venules
Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Retinal nerve fiber layer thickness
Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Components and waveform of VEPs
Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Pattern electroretinograms (PERGs)
Time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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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.
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
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 Landspitali University Hospital at 1 site in Iceland.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. 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 Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal vessels oxyhemoglobin saturation (time frame: Baseline. On the visit to the ambulatory Opthalamic department at Landspitali). 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 15 Apr 2025.