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临床试验/NCT04624737
NCT04624737已完成不适用

Intelligent Evaluation of Diabetic Retinopathy

Assistance Publique - Hôpitaux de Paris19 个研究点 分布在 1 个国家目标入组 3,183 人开始时间: 2020年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,183
试验地点
19
主要终点
Progression to severe retinopathy

研究概览

简要总结

Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up for a patient. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system.

An economic study will also be carried out.

详细描述

A cohort of 5,000 diabetic patients with different stages of DR will be recruited and followed for an average of 2 years. Each year, general data as well as ophthalmological data will be collected. Retinal images and videos of both eyes will be acquired using different imaging modalities including ultrawidefield photography, OCT and OCT angiography. The EviRed cohort will be split in two groups: one group of 1,000 patients (validation cohort) will be randomly selected during the inclusion period by unbalanced draw to be representative of the general diabetic population. Their data will be used for the validation of the algorithms. The data of the remaining 4,000 patients (training cohort) will be used to train the algorithms. The main objective will be the validation of the prognostic tool and evaluate how accurately the algorithm can predict progression to severe retinopathy in the following year. Secondary objectives will be to evaluate how accurately the algorithm can assess DR severity and individual components of severe DR, predict progression to severe retinopathy, visual decrease, occurrence of fluid in the macula area in an eye, DR progression in an eye and for a patient, as well as to compare prediction by algorithm with the one made by ophthalmologists based on the current DR classification and their clinical experience. Secondary outcome measures will be sensitivity, specificity and AUC of the algorithm for detecting DR severity and individual components of severe DR, prediction of DR progression towards a severe form of DR, visual decrease, occurrence of fluid in the macular area in an eye, as well as to predict DR progression in an eye and for a patient.

Economic study Healthcare reimbursement data will also be collected and analyzed from Health Insurance. The inclusion and follow-up period of the cohort runs from 12/21/2020 to 12/21/2024, with follow-up durations varying from 1 to 3 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • patient with type 1 or type 2 diabetes or other,
  • aged 18 years or more,
  • diabetes duration greater than 10 years for type 1 diabetes,
  • patient affiliated to social security,
  • women of childbearing potential who are unwilling or unable to use a method to avoid pregnancy; women who are pregnant or breastfeeding can be included in the study.

排除标准

  • ungradable fundus photography or OCT/OCTA imaging in both eyes,
  • previous treatment with vitrectomy in both eyes,
  • participant is unable or unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native language speaker),
  • Gestational diabetes vulnerable participants (minors, legally detained),
  • patients under legal protection (guardianship),
  • prisoners or subjects who are involuntarily incarcerated,
  • patients with untreated or treated proliferative DR and macular edema involving the center of the macula in both eyes or with panretinal photocoagulation and untreated or treated macular edema involving the center of the macula in both eyes.

结局指标

主要结局

Progression to severe retinopathy

时间窗: month 12

Progression towards severe diabetic retinopathy form.

次要结局

  • Algorithm performance(3 years)
  • Comparison of algorithms prediction to human prediction.(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (19)

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