临床试验/NCT04177082

NCT04177082已完成1 期

Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution

Cornea Associates of Texas2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2020年1月10日最近更新: 2022年10月19日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Cornea Associates of Texas
入组人数: 200
试验地点: 2
主要终点: K-Max

研究概览研究设计入排标准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

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

详细描述

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

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: 8 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

结局指标

主要结局

K-Max

时间窗: 12 Months

Change in K-Max, compared to baseline

K-Mean

时间窗: 12 Months

Change in K-Mean, compared to baseline

次要结局

Best Corrected Visual Acuity(12 Months)
Central Pachymetry(12 Months)
Uncorrected Visual Acuity(12 Months)

研究者

发起方

Cornea Associates of Texas

申办方类型

Other

责任方

Sponsor

研究点 (2)

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招募中

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终止

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