Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis (OPTICUS)
Assessment of Spondyloarthritis in an Acute Anterior Uveitis Inception Cohort: a Cross Sectional and Prospective Comparative Study of HLA-B27-positive and -negative Cases
Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Axial spondyloarthritis (axSpA), the hallmark of which is chronic sacroiliitis, can progress to vertebral fusion ("bamboo spine") in advanced cases. The prevalence of axSpA varies globally, ranging from 0.1% to 1.4%, with a higher incidence in men and a typical onset in the second or third decades of life. Diagnostic approaches include imaging techniques such as sacroiliac MRI and radiographs, alongside clinical criteria like inflammatory back pain, NSAID responsiveness, peripheral arthritis, and HLA-B27 positivity. Disease management primarily involves NSAIDs, with biologics used for refractory cases, and disease activity is monitored using indices such as BASDAI and ASDAS.
Acute anterior uveitis (AAU) is the most common extra-articular manifestation of SpA, particularly associated with HLA-B27 positivity. It often presents unilaterally with redness, pain, and photophobia but can lead to severe complications if inadequately treated. Around 50% of patients with HLA-B27-positive AAU have underlying SpA, and the prevalence of uveitis increases with longer disease duration. While the link between SpA and AAU is well-established, further research is needed to determine optimal systemic treatment and follow-up protocols. This study aims to assess the prevalence and clinical characteristics of SpA in patients presenting with AAU at ophthalmology clinics.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehmet P ATAGUNDUZ, MD
- Phone Number: +90(530) 939 45 94
- Email: pamiratagunduz@marmara.edu.tr
Study Contact Backup
- Name: Şeyma ÇOLAKOĞLU-ÖZKAYA, PhD
- Phone Number: +90(536) 519 88 60
- Email: seymacolakoglu5@gmail.com
Study Locations
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Maltepe
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Istanbul, Maltepe, Turkey, 34854
- Recruiting
- Marmara University School of medicine
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Contact:
- Mehmet P ATAGUNDUZ, MD
- Phone Number: +90(530) 939 45 94
- Email: pamiratagunduz@marmara.edu.tr
-
Contact:
- Şeyma ÇOLAKOĞLU-ÖZKAYA, PhD
- Phone Number: +90(536) 519 88 60
- Email: seymacolakoglu5@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with uveitis
Exclusion Criteria:
- patients diagnosed spondyloarthiritis before from the uveitis attack
- patients with infectious uveitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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main cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assesing the Prevalance of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis.
Time Frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
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Presence of undiagnosed or known Spondyloarthritis will be assessed in a cross-sectional manner at time of acute anterior uveitis.
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Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
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Assesing the Incidence of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis after first diagnosis.
Time Frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the fifth year after the inclusion of the last patient with acute anterior uveits.
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Development of an full-blown Spondyloarthritis will be assessed long-term in a prospective manner.
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Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the fifth year after the inclusion of the last patient with acute anterior uveits.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the HLA-B27 status among acute anterior uveitis patients with and without spondyloarthritis.
Time Frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of HLA-B27 is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
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HLA-B27 status will be assessed in patints with idiopathic acute- and spondyloarthritis associated anterior uveitis will be assessed.
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Cross-sectional anaylsis of the first two hundered patients for the prevalance of HLA-B27 is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPTICUS.001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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