Peking University Third Hospital
Beijing, China
Location status: Recruiting
NCT Number: NCT05605314
Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Beijing, China
Location status: Recruiting
Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
eye drop
Time frame: 2021.1~2028.1
Fill out the scale
Time frame: 2021.1~2028.1
The Schirmer I test was performed without topical anesthesia after all other examinations by slit lamp had been completed at least 15 minutes to avoid any effect of keratoconjunctival staining. A Schirmer test strip (Liaoning Meizilin Pharmaceutical Co., Ltd.) was placed on the outer one third of the temporal lower conjunctival fornix for 5 min. The strip was then removed, and the length of the wet filter paper was recorded in millimeters.
Time frame: 2021.1~2028.1
All participants were instilled a minimal volume fluorescein into the inferior temporal tear meniscus by fluorescein sodium ophthalmic test paper (Liaoning Meizilin Pharmaceutical Co., Ltd.) for the evaluation of tear menicus height (TMH) and fluorescein tear break-up time (FBUT) during slit lamp examination. Then, patients were asked to blink several times to ensure adequate mixing of the fluorescein dye with the tears. Under the cobalt blue light of the slit lamp microscope, TMH were recorded and the time interval between the last complete blink and the appearance of the first corneal dark spot was timed using a stopwatch. The average of three measurements was recorded as the FBUT.
Interested in participating?
Request InfoPeking University Third Hospital
Other
Acronym: pSS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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