Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- scale of Schirmer I test
研究概览
简要总结
To evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx), laser in situ keratomileusis (LASIK) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.
详细描述
Laser in situ keratomileusis (LASIK) with a microkeratome has been accepted wildly in the past 20 years. Gradually, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.
Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.
This prospective clinical study is going to analyze the short-term changes in ocular surface measures and tear inflammatory mediators after FLEx, LASIK and FS-LASIK procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 31 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •minimum age of 18 years(range from 18 year to 31 years); corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm; preoperative spherical equivalent refraction between
- •2.00 diopter (D) and -6.50 D; preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D; preoperative corneal curvature from 42.0 D to 46.0 D with a regular topographic pattern, verified with an Atlas topographer; monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery
排除标准
- •systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease); corneal abnormality or disease; a history of tear supplement usage or contact lens wear during the past year
结局指标
主要结局
scale of Schirmer I test
时间窗: up to 1month after surgery
scale of corneal fluorescein staining
时间窗: up to 1month after surgery
scale of noninvasive tear breakup time
时间窗: up to 1month after surgery
questionnaire of ocular surface disease index
时间窗: up to 1month after surgery
scale of central corneal sensitivity
时间窗: up to 1month after surgery
scale of tear meniscus height
时间窗: up to 1month after surgery
concentration of Interleukin-1α
时间窗: up to 1month after surgery
concentration of tumor necrosis factor-α
时间窗: up to 1month after surgery
concentration of nerve growth factor
时间窗: up to 1month after surgery
interferon-γ
时间窗: up to 1month after surgery
concentration of transforming growth factor-β1
时间窗: up to 1month after surgery
concentration of matrix metalloproteinase-9
时间窗: up to 1month after surgery
次要结局
- Correlation between Interleukin-1α and ocular surface disease index(up to 1month after surgery)
- Correlation between tumor necrosis factor-α and ocular surface disease index(up to 1month after surgery)
- Correlation between nerve growth factor and ocular surface disease index(up to 1month after surgery)
- Correlation between interferon-γ and ocular surface disease index(up to 1month after surgery)
- Correlation between transforming growth factor-β1 and ocular surface disease index(up to 1month after surgery)
- Correlation between matrix metalloproteinase-9 and ocular surface disease index(up to 1month after surgery)
- Correlation between Interleukin-1α and corneal fluorescein staining(up to 1month after surgery)
- Correlation between tumor necrosis factor-α and corneal fluorescein staining(up to 1month after surgery)
- Correlation between nerve growth factor and corneal fluorescein staining(up to 1month after surgery)
- Correlation between interferon-γ and corneal fluorescein staining(up to 1month after surgery)
- Correlation between transforming growth factor-β1 and corneal fluorescein staining(up to 1month after surgery)
- Correlation between matrix metalloproteinase-9 and corneal fluorescein staining(up to 1month after surgery)
研究者
Xingwu Zhong, MD PhD
Professor
Sun Yat-sen University