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临床试验/NCT02617368
NCT02617368已完成不适用

Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
Spherical Eccentricity (SphEcc)

研究概览

简要总结

Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

入选标准

  • diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
  • KISA index between 60 and 100% in the FFK eye (FFKG)
  • lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
  • uneventful ophthalmologic history (CG)
  • no indications of corneal pathology in slit-lamp biomicroscopy and Placido *disk-based videokeratography (CG)
  • KISA index value less than 60% (CG)
  • diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system (KCG)

排除标准

  • for all study groups:
  • previous incisional eye surgery
  • corneal scars and opacities
  • history of herpetic keratitis, severe eye dryness
  • pregnancy or nursing
  • current corneal infection
  • suspicion for glaucoma
  • IOP lowering treatment
  • underlying autoimmune disease

结局指标

主要结局

Spherical Eccentricity (SphEcc)

时间窗: One Day

Spherical Eccentricity is the asphericity that is calculated

Spherical Component (SphRmin)

时间窗: One Day

Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring

Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.

时间窗: One Day

Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.

Regular Astigmatism at the Center(AstC)

时间窗: One Day

the regular astigmatic component is calculated in the center and it is derived from the second order component of Fourier Analysis

Mean Astigmatism (MAst)

时间窗: One Day

Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)

Irregularitiy (Irr)

时间窗: one Day

Maximum Decentration (MaxDec)

时间窗: One Day

decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis

Regular Astigmatism at the Periphery (AstP)

时间窗: One day

the regular astigmatic component is calculated in the periphery and it is derived from the second order component of Fourier Analysis

Astigmatism at the Center plus the Irregularities (AstCir)

时间窗: One day

the irregularities of the cornea which can not be corrected by sphere, cylinder or prism and it is derived from higher order components of Fourier Analysis of Keratometric Data

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Labiris

Ass. Professor in Ophthalmology

Democritus University of Thrace

研究点 (1)

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