Computer Aided Diagnosis of Multiple Eye Fundus Diseases From Color Fundus Photograph

Diabetic Retinopathy Clinical Trial

Official title: A Prospective, Multicenter, Blinded Reading, Self Controlled, Superiority Priority Clinical Trial of Assisted Fundus Image Diagnosis Software for the Diagnosis of Multiple Eye Fundus Diseases

Status Completed

Clinical Trial Summary

Blindness can be caused by many ocular diseases, such as diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, pathologic myopia and glaucoma. Without timely diagnosis and adequate medical intervention, the visual impairment can become a great burden on individuals as well as the society. It is estimated that China has 110 million patients under the attack of diabetes, 180 million patients with hypertension, 120 million patients suffering from high myopia and 200 million people over 60 years old, which suggest a huge population at the risk of blindness. Despite of this crisis in public health, our society has no more than 3,000 ophthalmologists majoring in fundus oculi disease currently. As most of them assembling in metropolitan cities, health system in this field is frail in primary hospitals. Owing to this unreasonable distribution of medical resources, providing medical service to hundreds of millions of potential patients threatened with blindness is almost impossible.

To solve this problem, this software (MCS) was developed as a computer-aided diagnosis to help junior ophthalmologists to detect 13 major retina diseases from color fundus photographs. This study has been designed to validate the safety and efficiency of this device.

Clinical Trial Description

As a prospective clinical trial, This study enjoys multicentric, blind film reading, self-control and superiority test design. In total, 1,500 retinal fundus images from 750 individuals in need of fundus examination (one image for every single eye) were selected. Then a test group, along with a control group was set up in our study. For the test group, ophthalmologists read images with the aid of the assistant software(MCS). In contrast, the same work in the control group was finished by ophthalmologists independently. Meanwhile, the gold standard were obtained from the cooperation of senior ophthalmologists. Diagnoses of both groups were compared with those of the gold standard, thus the investigators could evaluated the safety and effectiveness of this assistant software in diagnosis.

The primary endpoint of this study is the superiority of the consistency rate of the test group. A diagnosis for an image is consistent if it gives the same negative result as the reference standard, or reveals any one condition indicated by the reference standard. The consistency rate is the rate of consistent diagnoses for all the involved images. One control group is designed, where each doctor reads and diagnoses, and give at most 3 possible conditions for each image. In the test group, doctors do the same thing with the help of this software. The investigators in the test group and control group are the same and they are chosen from ophthalmologists with 1~3 years experience. The reference standard of each fundus image is collaboratively given by retinal specialists/fellows from 5 centers. The investigator of XieHe center is the arbitrator if full consensus cannot be reached for any image during the building of reference standard. ;

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Diabetic Retinopathy
• Epiretinal Membrane
• Exudative Age Related Macular Degeneration
• Macular Degeneration
• Macular Holes
• Nonexudative Age-related Macular Degeneration
• Ocular Hypertension
• Optic Atrophy
• Pathologic Myopia
• Retinal Artery Occlusion
• Retinal Detachment
• Retinal Perforations
• Retinal Vein Occlusion
• Retinitis
• Retinitis Pigmentosa
• Suspect Glaucoma

• NCT number: NCT04723160
• Study type: Observational
• Source: Visionary Intelligence Ltd.
• Status: Completed
• Start date: August 10, 2020
• Completion date: May 30, 2021