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Ocular surface changes and meibomian gland dysfunction in rheumatologic patients: a Cross-Sectional analytical study

NCT ID NCT07810569

NEW Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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Not yet recruiting This study
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By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

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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Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients attending outpatient rheumatology services at Assiut University and Al-Azhar University with confirmed diagnoses of systemic autoimmune rheumatic diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, or Psoriatic Arthritis), alongside age- and sex-matched healthy control volunteers from the same geographic region with no systemic autoimmune disease or active ocular surface complaints.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis dry eye syndrome Meibomian Gland Dysfunction psoriatic arthritis rheumatoid arthritis Sjogren syndrome systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis Dry eye syndromes Meibomian gland dysfunction Psoriatic arthritis Rheumatoid arthritis Sjogren's syndrome Systemic lupus erythematosus

How to take part

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  1. The official record

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