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

NCT ID: NCT05689749

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-06-01

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.

Conditions

Inflammation; Sjogren's Syndrome; Gland; Inflammation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Sjögren's syndrome

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

Superb Microvascular Imaging (SMI) (Toshiba)

Intervention Type: DEVICE

To determine whether SMI has diagnostic value for detecting the inflammatory state in the lacrimal glands in Sjögren's syndrome and whether it has any superiority compared to Power Doppler and Color Doppler modalities.

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

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

Superb Microvascular Imaging (SMI) (Toshiba)

Intervention Type: DEVICE

To determine whether SMI has diagnostic value for detecting the inflammatory state in the lacrimal glands in Sjögren's syndrome and whether it has any superiority compared to Power Doppler and Color Doppler modalities.

Interventions

Superb Microvascular Imaging (SMI) (Toshiba)

To determine whether SMI has diagnostic value for detecting the inflammatory state in the lacrimal glands in Sjögren's syndrome and whether it has any superiority compared to Power Doppler and Color Doppler modalities.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

For the second group:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Ender Salbaş

Physical Medicine & Rehabilitation Specialist, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ender Salbas, MD

Role: STUDY_DIRECTOR

Nigde Omer Halisdemir University

Locations

Nigde Omer Halisdemir University

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ES02

Identifier Type: -

Identifier Source: org_study_id