NCT01682993终止3 期
Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety (Pachymetry, K-readings)
研究概览
简要总结
Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.
This randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patient age 18 - 40 years
- •Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia
排除标准
- •Allergy to one of the used substances
- •Tendency towards excessive scar formation
- •Pregnancy
- •Rheumatic diseases
- •Central corneal thickness below 450 µm
- •Active infection of the study eye
- •Previous corneal surgery of the study eye
结局指标
主要结局
Safety (Pachymetry, K-readings)
时间窗: 1 year
uncorrected visual acuity (UVCA)
时间窗: 1 year
best corrected visual acuity (BCVA)
时间窗: 1 year
次要结局
- Progression of ectatic disease (by use of maximum keratometry readings = Kmax)(1 year)
研究者
Gerald Schmidinger
MD, Assistant Professor
Medical University of Vienna
研究点 (2)
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