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临床试验/NCT04972695
NCT04972695已完成不适用

Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 个研究点 分布在 1 个国家目标入组 615 人开始时间: 2021年5月7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
615
试验地点
1
主要终点
Sensitivity and Specificity of an automated classification system for retinographies

研究概览

简要总结

Clinical, cross-sectional and prospective study to assess the images of the posterior pole of the retina of patients from the Glaucoma Unit of the IOBA and the Hospital Clínico Universitario de Valladolid during the period between May and December 2021.

The aim of the project is to provide a sufficient number of images from posterior pole retinographies in patients with suspected glaucoma or with diagnosis of glaucoma in order to determine the sensitivity and specificity of an automatic glaucoma screening algorithm developed by the company Transmural Biotech S.L.

研究设计

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

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Primary open angle glaucoma or ocular hypertension
  • •Signed informed consent
  • •Visual field examination within the last 12 months

排除标准

  • •Ocular or systemic pathologies that may interfere with the quality of the retinographic image or the results of the visual field
  • •Congenital anomalies of the papilla that seriously alter its structure
  • •High ametropia (> 10 diopters)
  • •Pharmacological Mydriasis contraindication.

结局指标

主要结局

Sensitivity and Specificity of an automated classification system for retinographies

时间窗: Day 0

次要结局

未报告次要终点

研究者

发起方
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
申办方类型
Other
责任方
Sponsor

研究点 (1)

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