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临床试验/NCT02943967
NCT02943967已完成不适用

Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Refractive results - spherical equivalent in diopters

研究概览

简要总结

The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

详细描述

Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet A (UVA) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. It is a relatively safe procedure with low rates of complications Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. This technique is also relatively safe procedure with low rates of complications. One of the most unwanted complications of this surgery and also rare is corneal ectasia.

Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.

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
23 Years 至 51 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • bilateral asymmetric topography with inferior steepening
  • corneal thickness of 440 micra at the thinnest point
  • inferior-to-superior index (I-S) between 1.0D and 1.4D
  • maximum keratometric steepness < 47.00D
  • stable refraction more than 1 year.

排除标准

  • forme fruste keratoconus and keratoconus
  • previous eye surgery
  • previous eye trauma
  • confirmed pregnancy

结局指标

主要结局

Refractive results - spherical equivalent in diopters

时间窗: 30 months

次要结局

  • Biomicroscopy findings with the slit lamp(30 months)
  • Aberrometric Results in root mean square(18 months)
  • Topographic results in diopters(30 months)
  • Visual acuity in logMar(30 months)
  • Pachymetric results in micra(30 months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Campos

medical doctor

Federal University of São Paulo

研究点 (2)

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