Computer Aided Diagnosis of Multiple Eye Fundus Diseases From Color Fundus Photograph
Condition: 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
MeSH terms: Optic Atrophy; Macular Degeneration; Diabetic Retinopathy; Retinitis; Retinal Vein Occlusion; Retinitis Pigmentosa; Retinal Detachment; Retinal Perforations; Epiretinal Membrane; Central Serous Chorioretinopathy; Retinal Artery Occlusion; Ocular Hypertension
Study type: Observational

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.
    

Intervention name(s): Software assisted imaging diagnosis
Intervention type(s): Diagnostic Test
Intervention description(s): In the test group, diagnoses are given with the help of the software.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patients who meet the eligibility criteria.
      
Keywords: multiple eye fundus diseases