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

Inflammation Clinical Trial

— SMI  

Official title:

Evaluation of Lacrimal Gland Involvement by Superb Microvascular Imaging Ultrasonography Technique in Patients With Sjögren Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689749
• Other study ID #: ES02
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Nigde Omer Halisdemir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 1, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Sjogren's Syndrome
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Nigde Omer Halisdemir University	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer's test	The tip of a special paper strip is placed inside the lower eyelid of each eye. During the test on both eyes, the eyes are asked to remain closed for 5 minutes. After 5 minutes the doctor removes the paper and measures how much is moistened.	1 year
Primary	Ocular Surface Disease Index (OSDI)	Participants will be asked to answer a 12-question questionnaire asking about various conditions and symptoms related to dry eye.It is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire were graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].	1 year
Primary	McMonnies Dry Eye Questionnaire	Participants will be asked to answer a 12-question questionnaire asking about various conditions and symptoms related to dry eye. It is presented on a single page and includes 12 questions that focus on clinical risk factors for DES. The questions employ polytomous response options that vary in number and type. For example, question 1 has three response categories consisting of yes (2), no (0), and uncertain (1), whereas question 9 has four response categories, consisting of never (0), sometimes (1), often (2), and constantly (3).	1 year
Primary	Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging	Four-stage classify will be use for grading these images; Grade 0: No vascularity in lacrimal and parotid gland, Grade 1: One or two focal color-encoded spots in lacrimal and parotid gland, Grade 2: One linear color-encoded line or more than two focal colorencoded spots in lacrimal and parotid gland, Grade 3: More than one linear color-encoded line in lacrimal and parotid gland	1 year