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

NCT05689749 | Completed

• 1 other identifier: ES02
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Sjogren's Syndrome; Gland; Inflammation

Keywords

superb microvascular imaging; microvascularization; Sjogren's syndrome; disease activitiy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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.

Device: Superb Microvascular Imaging (SMI) (Toshiba)

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.

Device: Superb Microvascular Imaging (SMI) (Toshiba)

Interventions

Superb Microvascular Imaging (SMI) (Toshiba) 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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients who diagnosed as Sjögren's syndrome as the first group. * Healthy participants as the second group

You may qualify if:

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

You may not qualify if:

• History of eye or face trauma or surgery
• Diabetes mellitus
• Pregnancy
• For the second group:
• asymptomatic eye (no dry eye or dry mouth),
• no previous trauma or surgery on face or eye,
• no history of systemic inflammatory disorders.
• History of eye or face trauma or surgery
• Diabetes mellitus
• Pregnancy
• Rheumatological diseases

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, 51700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammation; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ender Salbas, MD

  Nigde Omer Halisdemir University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine & Rehabilitation Specialist, MD

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 19, 2023
• Study Start: April 1, 2021
• Primary Completion: January 3, 2023
• Study Completion: June 1, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

TU (1)