Evaluation of Lacrimal Gland Involvement by Superb Microvascular Imaging Ultrasonography Technique in Patients With Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Schirmer's test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with Sjögren's syndrome
- •Age between 18-65
排除标准
- •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
结局指标
主要结局
Schirmer's test
时间窗: 1 year
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.
Ultrasonographic Evaluation; Superb Microvascular Imaging, GrayScale Imaging, Color Doppler Imaging, Power Doppler Imaging
时间窗: 1 year
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
Ocular Surface Disease Index (OSDI)
时间窗: 1 year
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=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\].
McMonnies Dry Eye Questionnaire
时间窗: 1 year
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).
次要结局
未报告次要终点
研究者
Ender Salbaş
Physical Medicine & Rehabilitation Specialist, MD
Nigde Omer Halisdemir University