Changes of Clinical Characteristics and Tear Film Biomarkers Following FS-LASIK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ocular surface disease index (OSDI)
研究概览
简要总结
to analyze the clinical and tear molecular profile up to 6 months after FS-LASIK surgery
详细描述
FS-LASIK is a refractive surgery technique widely used in China. To explore the role of inflammation and nerve in the occurrence and development of dry eyes after FS-LASIK by dynamically observing the ocular surface characteristics and the levels of inflammatory factors and neurotransmitters in the early and late stage after FS-LASIK.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who preparing for FS-LASIK with age between 18 and 45 years old
- •Provision of written informed consent.
排除标准
- •active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
- •Pregnant and lactating women, or those planning a pregnancy over the course of the study
- •Uncontrolled systemic disease
- •Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
结局指标
主要结局
ocular surface disease index (OSDI)
时间窗: from Pre-surgery to 6 months after surgery
OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.
Tear break-up time (TBUT)(s)
时间窗: from Pre-surgery to 6 months after surgery
BUT is the time from normal blinking to the first appearance of a break in the tear film.
Corneal fluorescein staining (CFS)
时间窗: from Pre-surgery to 6 months after surgery
The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15.
Schirmer Ⅰ test (SⅠt) (mm/5 minutes)
时间窗: from Pre-surgery to 6 months after surgery
The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.
次要结局
- the concentration of Interleukin-6 (IL-6) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of β-endorphin (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of Interleukin-17A (IL-17A) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of interferon-γ (IFN-γ)(pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of substance P (SP)(pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of neurotensin (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of oxytocin(pg/ml)(from Pre-surgery to 6 months after surgery)
- NPSI-Eye (range 0-100 score)(from Pre-surgery to 6 months after surgery)
- the concentration of Interleukin-1β（IL-1β) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of Interleukin-10 (IL-10) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of Interleukin-23 (IL-23) (pg/ml)(from Pre-surgery to 6 months after surgery)
- the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)(from Pre-surgery to 6 months after surgery)
- numerical rating scale (NRS)(from Pre-surgery to 6 months after surgery)
- Lissamine green staining(from Pre-surgery to 6 months after surgery)
- meibomian gland dropout rate(from Pre-surgery to 6 months after surgery)
- corneal sensitivity (range, 60-0 mm)(from Pre-surgery to 6 months after surgery)
- sub-basal corneal nerve density (mm/mm2)(from Pre-surgery to 6 months after surgery)