Short summary

The study consists of two sub-studies. A cross-sectional study in which we examine patients with known disease (6-24 months), by seeing whether we can detect retinal changes using non-invasive retinal markers and whether these changes may be similar in the two patient groups.

In the prospective sub-study, acute patients are examined using non-invasive retinal markers before treatment and again after 3 months of treatment. Healthy controls are included for comparison.

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Rationale

Introduction

It has previously been shown that retinal metabolism, measured by non-invasive markers, is affected by giant cell arteritis (GCA) - even in patients without noticeable symptoms from the eyes. Our study may help to investigate whether polymyalgia rheumatica patients (PMR) like GCA patients also have eye affection. This raises awareness of whether PMR patients also have a risk of developing significant eye disease and should therefore be seen by an ophthalmologist.

In addition, the study may help to clarify whether non-invasive eye measurements have the potential to track disease activity and predict the disease course of GCA and PMR. This can potentially contribute to the optimization of treatment and reduction in the risk of serious side effects, such as osteoporosis, diabetes and and glaucoma.

PURPOSE

In the cross-sectional study, the purpose is to describe the metabolic and structural ocular vascular changes, detected by non-invasive studies (retinal oximetry, EDI-OCT and retinal cargeometric analyzes) in patients with known GCA and PMR compared with healthy controls.

In the prospective study, we want to investigate whether, in newly diagnosed patients with GCA and PMR there are signs of subclinical ocular changes, detected by non-invasive studies (retinal oximetry, EDI-OCT and retinal cargeometric analyzes) at the time of diagnosis and after 3 months.

In addition, in the prospective study, we wish to investigate whether the ocular changes detected by non-invasive examinations (retinal oximetry, EDI-OCT and retinal cargeometric analyzes) correlate to inflammatory biomarkers cytokines, chemokines and NFL, and whether the inflammatory biomarkers can predict the course of the disease.

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Description of the cohort

Cross-sectional study: Patients with GCA or PMR through 6 - 24 months.

Patients for the cross-sectional study are found by rheumatologist Keld-Erik Byg at the department of rheumatology at Odense University Hospital.

Patients with the following ICD-10 codes are included in the study:

GCA patients (DM315, DM315A, DM316, DM316A) and PMR patients (DM353).

Prospective study: Patients with acute GCA or PMR. These patients are found by doctors at the department of rheumatology in Odense and by doctors at the department of rheumatology in Svendborg. Patients with the following ICD-10 codes are included in the study: GCA patients (DM315, DM315A, DM316, DM316A) and PMR patients (DM353). Participants must be over 50 years of age and have no previous retinal or optic nerve disease with the exception of a small number of retinal druses. The prospective study also allows non-proliferative diabetic retinopathy to increase the number of participants in the study. The controls must have had cataract surgery, be age-appropriate with the patient groups and otherwise have no major systemic diseases. The controls are found in connection with their cataract surgery in the waiting room before the surgery. Healthy controlss are found by Student Simon Lowater.

Data and biological material

Blood samples are taken from healthy controls and from patients participating in the prospective study at baseline and after 3 months, respectively. At each visit, 25ml of blood is taken for biobanking and analysis.

For patient examinations, demographic data, questionnaire (SF-36 v. 1, Birmingham Vasculitis Score v. 3, Charlson Comorbidity Index) are collected. In addition, data from the electronic patient record are collected.

Data from the patient record are read before the patient's consent by doctor Keld-Erik Byg or Torkell Ellingsen and are used to assess inclusion criteria and diagnosis as well as to obtain contact information.

Data from the patient record after consent is used to assess symptoms and disease duration, basis for diagnosis, imaginganalyses, blood tests, previous illness, previous treatments and are assessed by medical student Simon Lowater.

Collaborating researchers and departments

Department of ophtalmology, Odense University Hospital, Clinical Institute

• Prof. Jakob Grauslund, MD, PhD, Dr. Med.
• Jimmi Wied, MD.

Department of Rheumatology, Odense University Hospital, Clinical Institute

• Clinical Prof. Torkell Ellingsen, MD, PhD.
• Keld-Erik Byg, MD

Department of Rheumatology, Svendborg Sygehus, Clinical Institute

• Jens Pedersen, MD, PhD