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临床试验/NCT03355430
NCT03355430已完成不适用

Simultaneous Corneal Wavefront-Guided Trans-PRK and Corneal Collagen Crosslinking After ICRS Implantation for Moderate Keratoconus

Yonsei University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年7月7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
23
试验地点
1
主要终点
visual acuity

研究概览

简要总结

The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day.

详细描述

The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day. The dynamic Scheimpflug analyzer automatically calculated corneal deformation amplitude, radius values, and maximal concave power when the cornea is deformed to its greatest curvature by the air puff. The deformation amplitude is defined as the maximum amplitude when the cornea is deformed to its greatest concave curvature and is influenced by corneal stiffness. The radius values represent the central concave curvature at the highest concavity (depressed to the highest concavity), while maximal concave power is the inverse radius of the curvature at the highest concavity.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • intolerant to contact lenses
  • moderate keratoconus without apical scarring
  • if progression had been noted over the previous 6 months
  • All included patients underwent combined corneal wavefront-guided tPRK and CXL at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months) after ICRS implantation.

排除标准

  • central or para-central corneal scarring
  • central pachymetry < 400 microns
  • corneal endothelial cell density of less than 2000 cells/mm2
  • systemic autoimmune disease
  • a history of herpetic corneal disease
  • pregnancy
  • lactation
  • severe dry eye syndrome

结局指标

主要结局

visual acuity

时间窗: 6-month after tPRK-CXL

visual acuity in eyes undergoing combined corneal wavefront-guided transepithelial photorefractive keratectomy and accelerated corneal collagen cross-linking after intracorneal ring segment implantation in patients with moderate keratoconus

次要结局

  • Corneal indices(6-month after tPRK-CXL)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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