Clinical trial NCT04723160: Computer Aided Diagnosis of Multiple Eye Fundus Diseases From Color Fundus Photograph
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: multiple eye fundus diseases
Lead sponsor: Visionary Intelligence Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
name: Beijing Municipal Science & Technology Commission
First posted: 2021-01-25
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients who meet the eligibility criteria.

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.

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.

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.

Primary outcomes:
measure: consistent rate of diagnoses
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: sensitivity and specificity of software's diagnoses for each diseases
timeFrame: through study completion, an average of 1 year
measure: PPV and NPV of software's diagnoses for each diseases
timeFrame: through study completion, an average of 1 year
measure: full coincidence rate of software's diagnoses
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
city: Wenzhou
country: China
facility: Eye Hospital, WMU Zhejiang Eye Hospital
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College
name: You xin Chen, PHD
role: STUDY_CHAIR
References: