- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07810569
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
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.
연구 개요
상태
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Meibomian Gland Loss Assessed by Meiboscore
기간: Baseline
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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.
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Baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MGD in Rheumatologic Patients
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