Superb Microvascular Imaging Ultrasonography of Lacrimal Gland in Patients With Sjögren Syndrome (SMI)

Nigde Omer Halisdemir University

Status: Completed

Conditions: Inflammation; Sjogren's Syndrome; Gland; Inflammation

Treatments: Device: Superb Microvascular Imaging (SMI) (Toshiba)

Study type: Observational

Funder types: Other

Identifiers

NCT05689749

ES02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

42 participants in 2 patient groups

Participants with Sjögren's syndrome

Description:

Participants with the diagnose of Sjögren's syndrome; Patients with a confirmed diagnosis who are being followed and treated by a rheumatologist.

Treatment:

Device: Superb Microvascular Imaging (SMI) (Toshiba)

Volunteers who has not dry eye complaints and Sjögren's syndrome diagnosis.

Description:

Voluntary participants without any rheumatic disease diagnosis, without Sjögren's syndrome diagnosis, without dry eye complaints will constitute the other group.

Treatment:

Device: Superb Microvascular Imaging (SMI) (Toshiba)