Retinal Biomarkers in Parkinson´s Disease

NCT ID: NCT06929026

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2026-12-31

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. 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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Confirmed Parkinson Disease

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Reykjalundur Rehabilitation

UNKNOWN

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: collaborator

Landspitali University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thorunn Scheving Eliasdottir

Academic chair, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thorunn S Eliasdottir, PhD, CRNA

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Iceland and University of Iceland. Reykjalundur

Thorunn S Eliasdottir, PhD, CRNA

Role: PRINCIPAL_INVESTIGATOR

Landpitali the University Hopital of Iceland

Thorunn S Eliasdottir, PhD, CRNA

Role: PRINCIPAL_INVESTIGATOR

University of Iceland

Soley Thrainsdottir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Reykjalundur

Locations

Ophthalmic Outpatient Department Landspitali UH

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

VSN-22-129

Identifier Type: -

Identifier Source: org_study_id