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临床试验/NCT04805541
NCT04805541已完成不适用

Detection and Classification of Diabetic Retinopathy From Posterior Pole Images With A Deep Learning Model

URAL Telekomunikasyon San. Trade Inc.1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年2月1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
900
试验地点
1
主要终点
Sensitivity(vtDR)

研究概览

简要总结

The duration of diabetes is directly related to eye complications. Diabetic retinopathy affects 80 percent of those who have had diabetes for 20 years or more. At least 90% of new cases can be reduced with proper treatment and monitoring of the eyes. The longer a person has diabetes, the more likely it is to develop diabetic retinopathy. Each year in the United States, diabetic retinopathy accounts for 12% of all new cases of blindness. It is also the leading cause of blindness in people between the ages of 20 and 64. The most important complication of diabetes leading to vision loss is diabetic retinopathy. Depending on this, macular edema, bleeding into the retina and vitreous,neovascular glaucoma can cause blindness.

Diabetic retinopathy (DR) is a leading cause of vision-loss globally. Of an estimated 285 million people with diabetes mellitus worldwide, approximately one third have signs of DR and of these, a further one third of DR is vision-threatening DR, including diabetic macular edema (DME). Diabetic retinopathy is a retinal disease that can often be stopped with early diagnosis, but if neglected, it can lead to severe vision loss, including permanent blindness. Diabetes has high morbidity and there are millions of people who should be screened for diabetic retinopathy (DR). Annual eye screening is recommended for all diabetic patients since vision loss can be prevented if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is less than that needed to screen a growing diabetic population. Therefore, the automatic DR screening system will be able to screen more diabetic patients and diagnose them early.

EyeCheckup is an automated retinal screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DR. This study is designed to assess the safety and efficacy of EyeCheckup.

The study is a single center study to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy. EyeCheckup is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen for diabetic retinopathy (DR).

详细描述

This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR.

This study was carried out in a single center at Akdeniz University Faculty of Medicine with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting.

Methods and tools to be used in the study:

  • Fundus photography with non-mydriatic camera and classification of diabetic retinopathy with artificial intelligence algorithm,
  • Evaluation of seven field dilated fundus images by retina specialists and comparison of results for clinical validation of the system.

Clinical and laboratory tests to be performed:

研究设计

研究类型
Observational
观察模型
Case Only
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

  • A diagnosis of diabetes mellitus
  • Understanding of study and provision of written informed consent
  • 18 years of age or older
  • No history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)
  • Other than cataract surgery, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease No media opacity precluding good retinal photography

排除标准

  • No diagnosis of diabetes mellitus
  • Potential subject cannot understand study or informed consent
  • A history of retinal vascular disease other than diabetic retinopathy that may affect the appearance of the retina or optic disc
  • Previous intraocular surgery including cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy
  • Pregnant women or women with gestational diabetes mellitus
  • A media opacity in either eye that is severe enough to preclude good retinal photography
  • Permanent vision impairment in one or both eyes
  • The participant is contraindicated for imaging with fundus imaging systems used in the study:
  • Participant is hypersensitive to light
  • Participant recently received photodynamic therapy (PDT)
  • Participant uses drugs that cause photosensitivity

结局指标

主要结局

Sensitivity(vtDR)

时间窗: 1 visit (1 day)

Sensitivity for detecting vision threatening diabetic retinopathy

Specificity(mtmDR)

时间窗: 1 visit (1 day)

Specificity for detecting more than mild diabetic retinopathy

Sensitivity(mtmDR)

时间窗: 1 visit (1 day)

Sensitivity for detecting more than mild diabetic retinopathy

Specificity(vtDR)

时间窗: 1 visit (1 day)

Specificity for detecting vision threatening diabetic retinopathy

次要结局

  • Diagnosability(1 Day)
  • Non-Dilated EyeCheckup Usage(1 Day)

研究者

发起方
URAL Telekomunikasyon San. Trade Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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