Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

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.

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Key information

Conditions

Meibomian Gland Dysfunction Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Eyelid Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Salivary Gland Diseases Sjogren's Syndrome Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Stomatognathic Diseases Systemic Lupus Erythematosus Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

Age 18 years or older
Ability to provide written informed consent
For rheumatologic patients: Confirmed clinical diagnosis of one of the following autoimmune diseases:
Rheumatoid Arthritis (2010 ACR/EULAR classification criteria)
Systemic Lupus Erythematosus (2019 EULAR/ACR classification criteria)
Sjogren's Syndrome (2016 ACR/EULAR classification criteria)
Ankylosing Spondylitis (modified New York criteria)
Psoriatic Arthritis (CASPAR criteria)
For healthy controls: Age- and sex-matched individuals with no systemic autoimmune disease and no current ocular surface complaints

Exclusion criteria

Chronic use of topical antiglaucoma eye drops
Ocular surgery within the past 6 months
Active ocular infection or active uveitis
Contact lens wearers who have not discontinued wear for at least 2 weeks
History of ocular chemical burns
Pregnancy or lactation
Incomplete rheumatologic records or missing essential laboratory data

Treatment and study plan

Primary outcomes

Meibomian Gland Loss Assessed by Meiboscore

Time frame: Baseline

Meibomian gland drop-out is evaluated using non-contact infrared meibography and graded according to the Meiboscore scale for each eyelid (upper and lower): Grade 0 (no loss of meibomian glands), Grade 1 (gland loss involving less than one-third of the total area), Grade 2 (gland loss involving between one-third and two-thirds of the total area), and Grade 3 (gland loss involving more than two-thirds of the total area). Scores for the upper and lower eyelids are summed to yield a total Meiboscore per eye ranging from 0 to 6, where higher scores indicate greater meibomian gland loss and atrophy.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients: A Cross-Sectional Analytical Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 9, 2026
Registry last updated: Sep 9, 2026

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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Completed