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Completed

NCT Number: NCT07113834

Characteristics of Ankylosing Spondylitis Associated Uveitis

This study aims to understand the clinical characteristics associated with AAU in Egyptian AS patients, and the prognostic factors, in terms of the Corrected Distance Visual Acuity (CDVA).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University

Banhā, Cairo Governorate, 13111, Egypt

About this study

This is a one-year retrospective cohort study conducted at the Spine and Ophthalmology Clinics of Benha University - Faculty of Medicine, Egypt, between September 2023 and August 2024. The study aims to characterize the clinical features and identify prognostic factors affecting visual outcomes in patients with Ankylosing Spondylitis-associated Anterior Uveitis (ASAAU).

Patients included in this study were Egyptian nationals who initially presented to the Spine Clinic with systemic symptoms of ankylosing spondylitis (AS) and were subsequently referred to the Ophthalmology Clinic due to ophthalmic complaints. Only patients who were confirmed to have both AS (diagnosed according to the Modified New York criteria and radiographic imaging) and anterior uveitis (confirmed by slit-lamp examination and supported by Optical Coherence Tomography [OCT] and Fluorescein Angiography [FA]) were enrolled.

The final sample included 26 eyes from 22 patients who fulfilled the inclusion criteria. Patients were excluded if they were non-Egyptian, had other systemic autoimmune or immunologic conditions, had uveitis due to secondary causes, had undergone ocular surgeries, did not receive uveitis treatment, were lost to follow-up, or had incomplete medical records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Egyptian nationality.

Age: ≥ 18 years.

Confirmed diagnosis of Ankylosing Spondylitis (AS) according to the Modified New York Criteria, including:

Clinical symptoms (e.g., chronic inflammatory back pain, reduced lumbar motion, reduced chest expansion)

Radiographic evidence of sacroiliitis.

Confirmed diagnosis of Acute Anterior Uveitis (AAU) based on:

Ophthalmologic examination (e.g., slit-lamp biomicroscopy)

Ancillary testing (e.g., Optical Coherence Tomography [OCT] and/or Fluorescein Angiography [FA]).

Presentation to the Spine Clinic of Benha University - Faculty of Medicine between September 2023 and August 2024 with ophthalmic complaints, subsequently referred to the Ophthalmology Clinic.

Complete medical and ophthalmologic records available.

Received treatment for both AS and AAU.

At least one follow-up visit after initiation of treatment.

Exclusion criteria

  • Non-Egyptian patients.

History of other systemic autoimmune or immunological diseases (e.g., sarcoidosis, Behçet's disease, systemic lupus erythematosus).

Uveitis due to non-autoimmune secondary causes (e.g., infectious uveitis, trauma-related uveitis).

History of ocular surgery prior to the episode of AAU

Treatment and study plan

Adalimumab

Drug

A tumor necrosis factor-alpha (TNF-α) inhibitor used as a biologic agent for the treatment of ankylosing spondylitis. Administered subcutaneously as part of systemic immunomodulatory therapy.

Systemic corticosteroids

Drug

Oral or intravenous corticosteroids (e.g., prednisolone) used to suppress systemic inflammation in cases of active AS or severe uveitis.

Primary outcomes

  1. Change in Corrected Distance Visual Acuity (CDVA)

    Time frame: Baseline and 3-month follow-up

    CDVA was assessed at baseline (initial presentation) and after treatment (follow-up average of 3 months), using the Logarithm of the Minimum Angle of Resolution (logMAR) scale. Improvement or deterioration in CDVA was evaluated in relation to clinical characteristics, treatment modalities, and complication development.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Characteristics of Ankylosing Spondylitis Associated Uveitis: A Retrospective Study in Egyptian Patients

Acronym: uveitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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