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临床试验/PACTR201810577524718
PACTR201810577524718已完成未知

Corneal safety and stability in cases of Small incision lenticule extraction with collagen cross-linking (SMILE Xtra)

faculty of mediicne alexandria university0 个研究点目标入组 60 人开始时间: 2018年10月11日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60

研究概览

简要总结

There was a significant difference between the 2 groups regarding UDVA, CDVA, and MRSE at 1 month. In SMILE Xtra group, 90 % of eyes had postoperative UDVA of 20/20 and 97 % had UDVA of 20/30 at 24 months. At 24 months, 26 eyes (87 %) vs. 25 eyes (84 %) were within + 0.50 D of attempted correction in SMILE Xtra and SMILE groups respectively. Regarding stability, both groups showed improvement of MRSE at 1st month postoperative and remained stable along the 24 months of follow up. CRF and corneal densitometry was higher in SMILE Xtra group along the whole follow up period (p = 0.001).

研究设计

研究类型
Interventional

入排标准

年龄范围
19 Year(s) 至 44 Year(s)(—)
性别
All

入选标准

  • Patients > 18 years of age
  • Myopic error of > 6 D
  • Thinner cornea < 520 microns,
  • Abnormal corneal topography.

排除标准

  • Associated corneal pathology,
  • Established keratoconus,
  • Corneal thickness < 450 microns
  • Hyperopia or mixed astigmatism.

研究者

发起方
faculty of mediicne alexandria university

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