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Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

3. september 2026 opdateret af: Abanoub Saber Bakheet Gabra, Assiut University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Meibomian Gland Loss Assessed by Meiboscore
Tidsramme: 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.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

3. september 2026

Først indsendt, der opfyldte QC-kriterier

3. september 2026

Først opslået (Faktiske)

9. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MGD in Rheumatologic Patients

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