Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Ability to provide written informed consent

Rheumatoid Arthritis (2010 ACR/EULAR classification criteria)

Systemic Lupus Erythematosus (2019 EULAR/ACR classification criteria)

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Rheumatologic Patients
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

Meibomian Gland Loss Assessed by Meiboscore

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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