临床试验/NCT01459679

NCT01459679终止3 期

Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

American-European Congress of Ophthalmic Surgery83 个研究点分布在 1 个国家目标入组 1,721 人开始时间: 2012年7月最近更新: 2018年7月5日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方
入组人数: 1,721
试验地点: 83
主要终点: Mean change in maximum corneal curvature (Kmax) from baseline

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.

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: 12 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

VibeX Treatment Group B

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

干预措施: KXL System (30 mW/cm2) (Device)

VibeX Treatment Group A

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

干预措施: KXL System (15 mW/cm2) (Device)

VibeX Treatment Group A

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

干预措施: riboflavin ophthalmic solution (Drug)

VibeX Treatment Group B

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

干预措施: riboflavin ophthalmic solution (Drug)

VibeX Treatment Group C

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

干预措施: KXL System (45 mW/cm2) (Device)

VibeX Treatment Group C

Active Comparator

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

干预措施: riboflavin ophthalmic solution (Drug)

结局指标

主要结局

Mean change in maximum corneal curvature (Kmax) from baseline

时间窗: Month 6 or 12

次要结局

Comparison of treatment groups within each treatment indication(Month 6 and 12)

研究者

发起方

American-European Congress of Ophthalmic Surgery

申办方类型

Network

责任方

Sponsor

研究点 (83)

Loading locations...

相似试验

已完成

3 期

Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONICCrohn Disease

NCT00094458Centocor Ortho Biotech Services, L.L.C.508

已完成

2 期

Phase 2 Study for the Treatment of Superficial LipomasLipoma

NCT00608842Kythera Biopharmaceuticals62

终止

4 期

A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated AppendicitisAppendicitis

NCT00236912Johnson & Johnson Pharmaceutical Research & Development, L.L.C.139

已完成

3 期

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute SchizophreniaAcute Schizophrenia

NCT01396421Otsuka Pharmaceutical Development & Commercialization, Inc.636

招募中

不适用

Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCCHCC

NCT05592171University of Pisa60