Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

NCT07810569 — Not yet recruiting, 150 participants, Assiut University

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

Registry	NCT07810569
Status	Not yet recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Meibomian Gland Dysfunction, Dry Eye Syndromes, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, Psoriatic Arthritis
Dates	start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-09-09, last updated 2026-09-09

-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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+Arms and interventions

Arm	Type	Interventions	Description
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.
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.

+Outcome measures

Primary outcomes

Meibomian Gland Loss Assessed by Meiboscore [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.

+Eligibility

Sex: All, ages: 18 Years to any

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