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临床试验/NCT04763785
NCT04763785Unknown不适用

Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 4,800 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
4,800
试验地点
1
主要终点
Keratoconus identification

研究概览

简要总结

Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

详细描述

Keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. Corneal imaging is crucial in keratoconus detection and progression analysis. Detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus.

The Eyestar 900 is a swept-source OCT biometer and has the potential to be used for early keratoconus identification and progression analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Patients with all stages of keratoconus
  • •Patients with healthy corneas

排除标准

  • •Keratoconus patients with hydrops, status following hydrops
  • •Patients with degenerative corneal diseases
  • •Patients after corneal surgery

结局指标

主要结局

Keratoconus identification

时间窗: 2.5 years

Classification accuracy of the keratoconus identification algorithm for the Eyestar device in comparison to the gold standard (Belin-Ambrosio Enhanced Extasia Deviation Index) BAD_D in Pentacam images.

次要结局

  • Feasibility in clinical practice(2.5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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