Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

NCT07810569 | Not Yet Recruiting

• 1 other identifier: MGD in Rheumatologic Patients
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Sjogren's Syndrome; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

Ocular Surface Disease; Meibography; Meiboscore; Non-Invasive Tear Break-Up Time; Tear Meniscus Height; Ocular Surface Disease Index; Autoimmune Rheumatic Diseases; Corneal Fluorescein Staining

Outcome Measures

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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Sjogren's Syndrome; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Ophthalmology

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09