Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

Sponsor
Assiut University
Study ID
NCT07810569
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers. Meibomian glands are specialized glands in the eyelids that produce the lipid layer of tears, preventing tear evaporation. Systemic inflammation in rheumatologic conditions may affect these glands, leading to dry eye symptoms and ocular surface damage. A total of 150 participants (120 rheumatologic patients and 30 healthy controls) will be evaluated in a single cross-sectional examination. Rheumatologic diagnoses include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, and Psoriatic Arthritis. Participants will undergo a standardized series of non-invasive and minimally invasive eye examinations, including: * An ocular symptom questionnaire (Ocular Surface Disease Index) * Non-contact infrared meibography to assess meibomian gland loss (Meiboscore) * Non-invasive tear break-up time (NIBUT) and tear meniscus height measurements * Slit-lamp biomicroscopy and corneal fluorescein staining The study also examines how meibomian gland alterations correlate with systemic disease activity scores and inflammatory blood markers.

Key Dates

First listed
Sep 9, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Rheumatologic Patients
    Adult patients (aged 18 years or older) with an established diagnosis of one of five systemic autoimmune rheumatic diseases: Rheumatoid Arthritis (2010 ACR/EULAR criteria), Systemic Lupus Erythematosus (2019 EULAR/ACR criteria), Primary Sjogren's Syndrome (2016 ACR/EULAR criteria), Ankylosing Spondylitis (modified New York criteria), or Psoriatic Arthritis (CASPAR criteria) (n = 120). Participants undergo non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire.
  • Arm: Healthy Controls
    Age- and sex-matched healthy control subjects (aged 18 years or older) with no history of systemic autoimmune diseases and no active ocular surface complaints (n = 30). Participants undergo the same standardized ophthalmic assessment battery, including non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire.

Primary Outcome Measure

Meibomian Gland Loss Assessed by Meiboscore [ Time Frame: Baseline ]

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