Clinical trial NCT05689749: Superb Microvascular Imaging Ultrasonography of Lacrimal Gland in Patients With Sjögren Syndrome
Official title: Evaluation of Lacrimal Gland Involvement by Superb Microvascular Imaging Ultrasonography Technique in Patients With Sjögren Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Sjogren's Syndrome
Gland; Inflammation
Keywords: superb microvascular imaging
microvascularization
Sjogren's syndrome
disease activitiy
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients who diagnosed as Sjögren's syndrome as the first group.
* Healthy participants as the second group

Brief summary: A prospective study will be conducted to evaluate inflammatory activity in lacrimal glands due to Sjögren's syndrome on Superb Microvascular Imaging (SMI), gray scale ultrasound (US), color Doppler US and Power Doppler US.

Detailed description: In the disease activity index recommended by EULAR, the European Rheumatology Association, to evaluate the disease activity of patients with Sjögren's syndrome, it is recommended to measure the swelling in the gland by performing a clinical examination for glandular activity. However, it is not practical to measure the size of these glands due to their location.

In studies in which lacrimal glands were evaluated by ultrasonographic methods, parameters such as gland size measurement, gland heterogeneity and Doppler activity were reported to be very successful in differentiating patients from healthy controls.

Determining the presence and characteristics of vascular flow is an important part of ultrasonographic examinations. However, small vessels and low velocities are not always possible to detect with conventional color and power Doppler ultrasound. Sonographic examination will be inconclusive, especially if the presence of vascular flow or activity needs to be addressed as a basis for diagnosis and follow-up. Superb Microvascular Imaging (SMI) is a new vascular imaging mode that provides low speed and visualization of microvascular flow. SMI uses an algorithm that can suppress parasitic reverberations to extract flow signals and displays this information as a color overlay image or a monochromatic or color flow map.There are studies that report that Superb Microvascular Imaging (SMI), a new and up-to-date Ultrasonography technology, is more sensitive in detecting the activity of Rheumatic diseases. In this respect, there are no studies evaluating the inflammatory activity of lacrimal glands with SMI method.

Therefore, a prospective study will be conducted to evaluate the inflammation detecting performance of SMI, gray scale US, color Doppler US and Power Doppler US. The null hypothesis that there is no difference between Doppler US and SMI methods in the detection of increased inflammatory activity in Sjögren's syndrome patients.

Eligibility criteria: For the first group:

Inclusion Criteria:

* Patients diagnosed with Sjögren's syndrome
* Age between 18-65

Exclusion Criteria:

* History of eye or face trauma or surgery
* Diabetes mellitus
* Pregnancy

For the second group:

Inclusion Criteria:

* asymptomatic eye (no dry eye or dry mouth),
* no previous trauma or surgery on face or eye,
* no history of systemic inflammatory disorders.

Exclusion Criteria:

* History of eye or face trauma or surgery
* Diabetes mellitus
* Pregnancy
* Rheumatological diseases

Primary outcomes:
measure: Schirmer's test
timeFrame: 1 year
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 1 year
measure: McMonnies Dry Eye Questionnaire
timeFrame: 1 year
measure: Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir University
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Ender Salbas, MD
role: STUDY_DIRECTOR
References: