NCT02625467已完成1 期
Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)
Instituto de Oftalmología Fundación Conde de Valenciana0 个研究点目标入组 28 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.
- •Need of surgical procedure
- •No endothelial scar
- •Best corrected visual acuity <20/40
- •Contact lens intolerance
- •Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter
排除标准
- •Contraindication for any of the techniques evaluated.
- •Requiring additional surgical procedures.
- •Diagnostic of other ectasia that were not primary keratoconus.
研究组 & 干预措施
Penetrating keratoplasty
Experimental
Conventional penetrating keratoplasty technique
干预措施: Penetrating keratoplasty (Procedure)
Penetrating keratoplasty
Experimental
Conventional penetrating keratoplasty technique
干预措施: Treatment posterior to surgery (Drug)
PALK
Experimental
Pachymetry and Excimer laser assisted lamellar keratoplasty
干预措施: Pachymetry and Excimer laser assisted lamellar keratoplasty (Procedure)
PALK
Experimental
Pachymetry and Excimer laser assisted lamellar keratoplasty
干预措施: Treatment posterior to surgery (Drug)
结局指标
主要结局
Visual acuity
时间窗: 6 months
Uncorrected and corrected distance visual acuity
次要结局
- Corneal measurements: keratometries.(6 months)
- Corneal measurements: pachymetry(6 months)
- Corneal aberrometry: Coma, spherical aberration and trefoil(6 months)
- Corneal measurements: anterior and posterior elevation(6 months)
研究者
相似试验
已完成
不适用
Diagnostic Evaluation of Keratoconus Using Corneal Topography and Machine Learning.KeratoconusJPRN-UMIN000040128Kitasato University271
尚未招募
不适用
Eye changes after Cataract surgeryCTRI/2018/03/012476Government Medical College and Hospital Chandigarh
Unknown
不适用
Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.KeratoconusNCT03879421Reham Mahmoud Abdelrahman44
已完成
不适用
Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and PrecisionCorneal ThicknessNCT05283343Topcon Corporation30
已完成
不适用
Treatment of Keratoconus With Advanced Corneal CrosslinkingKeratoconusNCT02425150Umeå University120