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临床试验/NCT03598634
NCT03598634已完成不适用

Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up

University of Molise0 个研究点目标入组 32 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
Best-corrected visual acuity after treatment

研究概览

简要总结

To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

详细描述

The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.

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

入选标准

  • patients with evolving keratoconus
  • aged between 18 and 40 years
  • no evidence of corneal scarring

排除标准

  • patients with central and paracentral corneal opacities
  • Vogt's striae
  • previous intraocular surgery
  • history of herpetic keratitis
  • history of severe dry eye
  • concomitant autoimmune diseases.

结局指标

主要结局

Best-corrected visual acuity after treatment

时间窗: up to 48 months from the recruitment

* Scale name: Early treatment diabetic retinopathy study (ETDRS) charts. * Scale range 0-1. * highest value of the range (corresponding to 20/20): 0 * lowest value of the range (corresponding to 20/200): 1

次要结局

未报告次要终点

研究者

发起方
University of Molise
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciro Costagliola

Full Professor in Ophthalmology

University of Molise

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