Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Bulbar conjunctival immune cell Status by IVCM
研究概览
简要总结
In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to consent to study
- •Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity
- •Positive vital dye staining of the cornea
- •At least one of the following objective signs: (Schirmer I <10 mm at 5 minutes), decreased (<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of <10 seconds, positive vital dye staining of the conjunctiva
- •For Age-Match Controls
- •Inclusion Criteria:
- •Between the ages of 18-89
- •The ability to provide informed consent for study inclusion
- •Clear, healthy cornea
- •Normal tear meniscus (> 0.3 mm)
- •For Dry Eye Disease Participants
排除标准
- •History of contact lens wear in the past 3 months
- •History of ocular surgery in the past 6 months
- •Active ocular allergies
- •History of ocular infection in the past 3 months
- •History of diabetes
- •History of topical or systemic anti-inflammatory therapy in the past 1 month
- •For Age-Match Controls
- •Exclusion Criteria:
- •History of ocular or eyelid surgery within the past 12 months
- •History of herpetic or other infectious keratitis or other inflammatory eye disease
- •History of any other acute ocular disease
- •Current use of topical medications (not including artificial tears)
- •Current use of contact lenses
- •History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy
- •History of cancer elsewhere in the body which is currently under systemic chemotherapy
- •Current glaucoma disease requiring use of glaucoma drops
- •History of Diabetes mellitus
- •Current diagnosis of dry eye disease
结局指标
主要结局
Bulbar conjunctival immune cell Status by IVCM
时间窗: Visit 1
Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
Peripheral Corneal Immune cell Status by IVCM
时间窗: Visit 1
Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells
次要结局
- Clinical Parameter: Schirmer's II test(Visit 1)
- Clinical Parameter: Conjunctival staining with lissamine green(Visit 1)
- Clinical Parameter: Ocular Surface Disease Index (OSDI)(Visit 1)
- Clinical Parameter: Tear Break Up Time (TBUT)(Visit 1)
- Clinical Parameter: Corneal staining with fluorescein(Visit 1)
- Clinical Parameter: Conjunctival redness(Visit 1)