Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Corneal fluorescein staining (CFS)
研究概览
简要总结
In recent years, many scholars have studied the ocular surface damage of patients with dry eye disease（DED）after FS-LASIK, but there has been a lack of comprehensive observation and research on the relationship and difference between dry eye （DE）patients with and without LASIK. Therefore, the purpose of this study was to investigate the characteristics of ocular surface and cytokines after FS-LASIK, and further explain the pathogenesis of chronic dry eyes after FS-LASIK. In addition, we will also compare clinical characteristics and tear neuropeptide concentrations in patients with dry eye disease (DED) with and without chronic ocular pain following FS-LASIK, and to investigate correlations between ocular pain, clinical characteristics, and tear neuropeptide levels.
详细描述
A single visit cross-sectional study was performed. Approximately 40 chronic dry eye participants who had FS-LASIK more than 12month prior were recruited. Approximately 40 dry eye participants without refractive surgery history and 40 healthy participants without dry eye were also recruited as control groups. In addition, the patients with post-FS-LASIK DED were categorized into two groups based on the presence or absence of chronic ocular pain: (1) post-FS-LASIK DED patients with chronic ocular pain and (2) post-FS-LASIK DED patients without chronic ocular pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18years to 40 years
- •Male or female
- •DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without FS-LASIK
- •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, which in the judgment of the investigator may interfere with the interpretation of the study results.
- •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
Corneal fluorescein staining (CFS)
时间窗: baseline
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.
ocular surface disease index (OSDI)
时间窗: baseline
OSDI is one of the most frequently used questionnaires for evaluation of dry eye . 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: baseline
BUT is the time from normal blinking to the first appearance of a break in the tear film.
numerical rating scale (NRS)
时间窗: baseline
The NRS was used to evaluate ocular pain and consists of a numbered line from 0 to 10 scores that measures pain intensity: 0-1: no pain; 2-4: mild pain; 5-7: moderate pain; and 8-10: severe pain.
NPSI-Eye (range 0-100 score)
时间窗: baseline
Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye) (range 0-100 over a 24-hour recall period)
次要结局
- the concentration of Interleukin-6 (IL-6) (pg/ml)(baseline)
- the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)(baseline)
- the concentration of neurotensin(pg/ml)(baseline)
- corneal sensitivity (range, 60-0 mm)(baseline)
- Hamilton anxiety scale(baseline)
- the concentration of Interleukin-17A (IL-17A) (pg/ml)(baseline)
- the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)(baseline)
- Schirmer Ⅰ test (SⅠt) (mm/5 minutes)(baseline)
- tear meniscus height (TMH)(mm)(baseline)
- meibomian gland dropout rate(baseline)
- Hamilton Depression scale(baseline)
- the concentration of interferon-γ (IFN-γ)(pg/ml)(baseline)
- the concentration of Interleukin-1β（IL-1β) (pg/ml)(baseline)
- the concentration of Interleukin-10 (IL-10) (pg/ml)(baseline)
- the concentration of Interleukin-23 (IL-23) (pg/ml)(baseline)
- the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)(baseline)
- the concentration of substance P (SP)(pg/ml)(baseline)
- the concentration of oxytocin(pg/ml)(baseline)
- the concentration of β-endorphin (pg/ml)(baseline)
- Lissamine green staining(baseline)
- sub-basal corneal nerve density (mm/mm2)(baseline)