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临床试验/NCT03437018
NCT03437018已完成不适用

COMPARISON OF MONITORING OF MODERATE DIABETIC RETINOPATHY BY TELE-EXPERTISE AND CONVENTIONAL OPHTHALMOLOGICAL CONSULTATION

Centre Hospitalier Sud Francilien2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2019年10月10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
97
试验地点
2
主要终点
classification of diabetic retinopathy (DR)

研究概览

简要总结

The aim of this study is to evaluate the monitoring of moderate diabetic retinopathy by tele-expertise

详细描述

This study compares 2 strategies of monitoring of moderate diabetic retinopathy (RD).After a consultation with an orthoptist for measurement of visual acuity, measurement of ocular tone by pulsed air tonometer, retinography pictures (9 photographs: one of the posterior pole and 8 of the retinal periphery) and Optical Coherence Tomography (OCT), results are evaluated on-site by an ophthalmologist and then sent through a secure medical online application to an ophthalmologist expert in RD for assessment. Each patient is his own control.

研究设计

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

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 complicated diabetes mellitus with moderate retinopathy

排除标准

  • Patient deprived of liberty by judicial or administrative decision
  • Person subject to a legal protection measure
  • Patient already involved in another clinical trial protocol

结局指标

主要结局

classification of diabetic retinopathy (DR)

时间窗: 1 month

DR is classified in 3 stages : moderate non proliferative DR, severe non proliferative DR, and proliferative DR

次要结局

  • follow-up strategy(1 month)
  • classification of macular edema(1 month)
  • medical time necessary for examination and analyse(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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