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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04723160
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : December 30, 2021
Peking University First Hospital
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Visionary Intelligence Ltd.

Brief 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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Retinal Vein Occlusion Retinal Artery Occlusion Central Serous Chorioretinopathy Pathologic Myopia Retinitis Pigmentosa Epiretinal Membrane Macular Holes Nonexudative Age-related Macular Degeneration Exudative Age Related Macular Degeneration Suspect Glaucoma Optic Atrophy Retinal Detachment Diagnostic Test: Software assisted imaging diagnosis

Detailed 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.

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Study Type : Observational
Actual Enrollment : 748 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : August 10, 2020
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : May 30, 2021

Group/Cohort Intervention/treatment
Test Group
ophthalmologists read images applying the assistant software
Diagnostic Test: Software assisted imaging diagnosis
In the test group, diagnoses are given with the help of the software.

Control Group
ophthalmologists read images independently

Primary Outcome Measures :
  1. consistent rate of diagnoses [ Time Frame: through study completion, an average of 1 year ]

    Formula for calculation: consistent rate of diagnoses=number of images with consistent diagnosis/ total number of images × 100%.

    Method: the diagnoses from the test group and the control group were compared with diagnoses from the gold standard. For each image, if one or more diagnoses were consistent with those of the gold standard, which means at least one label existed in the intersection of diagnoses from the test group(or the control group)and those from the gold standard, it would be classified as "image with consistent diagnosis". Otherwise, it would be classified as "image without consistent diagnosis". After above-mentioned steps, the investigators had obtained the number of images with consistent diagnosis in each group. As images with 1-2 labels account for the majority in actual work, the investigators stipulated that each image in both groups could be marked with 3 labels at most in case of invalid improvement in consistent rate owing to multiple selections.

Secondary Outcome Measures :
  1. sensitivity and specificity of software's diagnoses for each diseases [ Time Frame: through study completion, an average of 1 year ]
    sensitivity and specificity of software's diagnoses for each diseases

  2. PPV and NPV of software's diagnoses for each diseases [ Time Frame: through study completion, an average of 1 year ]
    PPV(Positive Predictive Value) and NPV(Negative Predictive Value) of software's diagnoses for each diseases

  3. full coincidence rate of software's diagnoses [ Time Frame: through study completion, an average of 1 year ]
    The full consistency rate is the rate of fully consistent diagnoses in the set. A diagnosis is fully consistent it is exactly the same as the reference standard.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patients who meet the eligibility criteria.

Inclusion Criteria:

  • Age between 18 and 75.
  • Anyone need to take fundus photograph in clinical.
  • Understand the study and volunteer to sign the informed consent.
  • For fundus images of participants, the optic disc, fovea, the upper and lower vessel bow should be included in the fundus field.

Exclusion Criteria:

  • Participants has any eye that cannot take fundus photos.
  • Participants have joined or is participating in other clinical trial within one month.
  • Participants who have any other issue that cannot be enrolled.
  • Participants with cloudy refractive media that cannot take fundus photos or get clouding fundus photos.
  • Participants with low quality fundus photos like incompetent vision field, overexposed/underexposed, out of focus, too many shadow or dirties and so on.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04723160

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China, Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
BeiJing, Beijing, China, 100730
China, Hebei
The Second Hospital of Hebei Medical University
Shijia Zhuang, Hebei, China
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China
China, Tianjin
Tianjin Medical University Eye Hospital
Tianjin, Tianjin, China
China, Zhejiang
Eye Hospital, WMU Zhejiang Eye Hospital
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Visionary Intelligence Ltd.
Peking University First Hospital
Beijing Municipal Science & Technology Commission
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Study Chair: You xin Chen, PHD Peking Union Medical College
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Responsible Party: Visionary Intelligence Ltd. Identifier: NCT04723160    
Other Study ID Numbers: BLG-20200101
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Visionary Intelligence Ltd.:
multiple eye fundus diseases
Additional relevant MeSH terms:
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Optic Atrophy
Macular Degeneration
Diabetic Retinopathy
Retinal Vein Occlusion
Retinitis Pigmentosa
Retinal Detachment
Retinal Perforations
Epiretinal Membrane
Central Serous Chorioretinopathy
Retinal Artery Occlusion
Ocular Hypertension
Eye Diseases
Retinal Degeneration
Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Venous Thrombosis
Embolism and Thrombosis
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Arterial Occlusive Diseases
Optic Nerve Diseases
Cranial Nerve Diseases