Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography
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
- 是
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
Mauro Campos
medical doctor
Federal University of São Paulo
