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临床试验/NCT06406933
NCT06406933招募中不适用

Saliva Conductivity as A Novel Screening Test for Dry Eye Disease and Sjögren's Syndrome

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Ocular Surface Disease Index (OSDI) questionnaire

研究概览

简要总结

Dry eye disease, or keratoconjunctivitis sicca, is one of the most common diseases encountered at ophthalmologic clinics. Patient with dry eye disease commonly presented foreign body sensation, red eye, blurred vision, etc. Numerous treatments for dry eye disease are proposed due to its multifactorial etiology. Sjögren syndrome, which is one of the main etiologies of dry eye disease, is an autoimmune disease characterized by dysfunction of lacrimal and salivary glands. Although dry eye status can be easily examined by ocular surface staining, the methods quantifying salivary flow rate are hard to performed clinically, such as salivary gland scintigraphy and sialometry. Furthermore, disease activity could only rely on serum markers or salivary gland ultrasound. Recently, a portable device measuring salivary conductivity is believed to assess fluid status and renal function. Interestingly, the composition of salivary electrolytes in patients with Sjögren syndrome is different from those with other causes of hyposalivation. Thus, this study aims to evaluate whether salivary conductivity in combination with ocular surface staining can be a non-invasive diagnostic test for primary Sjögren syndrome among people with dry eye disease.

详细描述

Dry eye disease is prevalent among patients presenting with ocular surface diseases, with rates ranging from 5-50% in recent years. In the United States, approximately sixteen million people are affected by this condition. Dry eye patients often experience ocular surface damage, such as punctate epithelial keratitis, superior limbic keratoconjunctivitis, and filamentary keratitis, due to impaired tear lubrication of the cornea. The etiology of dry eye disease is multifactorial, making diagnosis challenging and requiring comprehensive medical history inquiry and various ocular surface staining techniques. In Taiwan, fluorescein strips are commonly used to assess corneal damage severity and tear break-up time to evaluate tear film abnormalities. Recent research utilizing in vivo confocal microscopy has revealed lower sub-basal nerve fiber numbers and higher dendritic cell densities in the cornea of dry eye patients with immune causes.

Dry eye disease was redefined as a multifactorial condition at the International Dry Eye Workshop II (DEWS II) in 2017, categorized into aqueous deficient dry eye (ADDE) and evaporative dry eye (EDE). In Taiwan, Sjögren's Syndrome (SS) is a primary cause of aqueous deficient dry eye, occurring in approximately 4.8% of dry eye disease patients. SS is a chronic autoimmune disease characterized by lymphocyte infiltration of exocrine glands like the salivary and lacrimal glands. If SS occurs without other autoimmune diseases, it is referred to as primary Sjögren's Syndrome (pSS). Globally, the prevalence of pSS is approximately 60.82 per 100,000 people, with an incidence rate of 6.92 per 100,000 people. Conventional diagnostic methods for salivary dysfunction, such as salivary scintigraphy and parotid sialography, are costly and time-consuming. Following SS diagnosis, comprehensive blood tests, including CBC, DC, ESR, CRP, BUN, Cre, Na, K, HCO3, and serum immunomarkers (ANA, anti-SSA/Ro, anti-SSB/La, RF), are typically advised. The study aims to investigate saliva conductivity as a diagnostic and disease activity monitoring tool for primary Sjögren's syndrome in dry eye syndrome patients and its association with ocular surface damage and tear secretion volume.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 20 and older
  • Patients with normal and dry eye syndrome

排除标准

  • Hepatitis C
  • Acquired immunodeficiency syndrome
  • Intestinal amyloidosis
  • Open pulmonary tuberculosis
  • Graft-versus-host disease
  • Rheumatoid or lupus erythematosus and other autoimmune diseases
  • IgG4-related diseases
  • Head and neck radiation therapy
  • History of infectious keratitis
  • History of ophthalmic surgery
  • Wear contact lenses in the month before the trial
  • Chew betel nuts or smoke within one month before the trial

研究组 & 干预措施

new-pSS

Newly diagnosed primary Sjögren's syndrome patients

干预措施: Carbomer Gel/Jelly (Drug)

Sjögren's syndrome

Patients diagnosed with Sjögren's syndrome and who have undergone treatment: Need to undergo major illness card registration.

干预措施: Carbomer Gel/Jelly (Drug)

dry eye

Those with symptoms of dry eyes (such as a sensation of foreign bodies in the eyes, sensitivity to light, tearing, etc.) but without symptoms of dry mouth (such as frequent drinking of water).

干预措施: Carbomer Gel/Jelly (Drug)

结局指标

主要结局

Ocular Surface Disease Index (OSDI) questionnaire

时间窗: 2023-2025

To evaluate the severity of dry eye symptoms.Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.

次要结局

  • Tear Film Break-up Time(2023-2025)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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