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临床试验/NCT03584555
NCT03584555已完成不适用

Comparison of Clinical Outcomes of Small-incision Lenticule Extraction (SMILE) Between Different Cap Thickness.

Yonsei University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Uncorrected Distance Vision Acuity

研究概览

简要总结

In the past two decades, the femtosecond laser (FSL) technology has been introduced in the corneal refractive surgery filed, and brought a remarkable innovation. It can make tissue dissection through photodisruption and plasma cavitation. Initially, the FSL was used predominantly to make a corneal flap when performing laser in situ keratomileusis (LASIK), which is followed by stromal ablation using excimer laser. A new surgical technique called femtosecond lenticule extraction (FLEx) has been developed that uses only FSL to dissect two interfaces to create refractive lenticule and then remove it, which is very similar with LASIK. Small incision lenticule extraction (SMILE) which is the advanced form of all-in-one FSL refractive technique does not make a corneal flap rather make small incision where the separated refractive lenticule is removed through, and the upper part of the corneal tissue is called cap. Since the clinical outcomes of SMILE were firstly published in 2011, SMILE has been widely used for correction of myopia or myopic astigmatism worldwide. SMILE provides excellent visual outcomes and has advantages including a lesser decrease in corneal sensitivity and absence of flap related complications compared to LASIK.

Because corneal ectasia after refractive surgery is the one of most terrifying complication, corneal biomechanics has been drawn interests to many researchers and clinicians. Theoretically, SMILE may preserve corneal biomechanics better than LASIK, because the anterior stroma which is stiffer than the posterior stroma remains intact in SMILE. However, there are some controversies, because previous studies investigating corneal biomechanics have been reported inconsistent outcomes, although SMILE has been reported equal to or better than LASIK. Weakening of corneal biomechanics and iatrogenic corneal ectasia have also been reported after SMILE. In addition, because the tensile strength of cornea gradually decreases as it goes backwards, creating deeper refractive lenticule may result in stronger cornea by preserving more of anterior lamellae of the cornea. But on the contrary, leaving sufficient residual stromal bed has been known to be important in preventing iatrogenic corneal ectasia, hence creating thin cap may be effective and desirable. Although many researches have been investigated the difference in biomechanical response between SMILE and LASIK, there are few studies evaluating the dependence of cap thickness on postoperative biomechanical strength after SMILE. El-Massry et al. reported that the thicker cap thickness showed higher postoperative corneal hysteresis (CH) and corneal resistance factor (CRF) with Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Depew, NY) which may not be optimal for a clear description of the viscosity and elasticity of the cornea,3 ; however, other studies have been presented that there is no significant difference of corneal biomechanics with cap thickness. There is no comparative human study using Corvis ST (Oculus, Wetzlar, Germany) despite presence of the study using Corvis ST in rabbit eyes. Furthermore, no prospective study with large number of subjects has been performed to date.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age of 20 years or older.
  • Who is willing to get SMILE surgery

排除标准

  • severe ocular surface disease
  • any corneal disease, cataract, glaucoma, macular disease, or previous history of intraocular or corneal surgery
  • Patients with suspicion of keratoconus on corneal topography

结局指标

主要结局

Uncorrected Distance Vision Acuity

时间窗: from preoperative to postoperative 6 months

Uncorrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.

Corrected Distance vision Acuity

时间窗: from preoperative to postoperative 6 months

Corrected Distance Vision Acuity in logMAR scale will be compared between the two groups at each time point.

次要结局

  • 1.Total higher order aberration at each time point between the two groups.(from preoperative to postoperative 6 months)
  • 2.Total higher order aberration changes from baseline at each postoperative time point between the two groups.(from preoperative to postoperative 6 months)
  • 3.Spherical aberration at each time point between the two groups.(from preoperative to postoperative 6 months)
  • 4.Spherical aberration changes from baseline at each postoperative time point between the two groups.(from preoperative to postoperative 6 months)
  • 5.Coma aberration at each time point between the two groups.(from preoperative to postoperative 6 months)
  • 6.Coma aberration changes from baseline at each postoperative time point between the two groups.(from preoperative to postoperative 6 months)
  • 7.Deformation amplitude ratio (DA ratio) at each time point between the two groups.(from preoperative to postoperative 6 months)
  • 8.DA ratio changes from baseline at each postoperative time point between the two groups.(from preoperative to postoperative 6 months)
  • 9.Stiffness parameter at first applanation (SP-A1) at each time point between the two groups.(from preoperative to postoperative 6 months)
  • 10.SP-A1 changes from baseline at each postoperative time point between the two groups.(from preoperative to postoperative 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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