Skip to main content
. 2023 Nov 15;2023(11):CD014911. doi: 10.1002/14651858.CD014911.pub2

Kuo 2020.

Study characteristics
Patient Sampling Retrospective, single‐centre (Taiwan), case‐control study. The investigators retrospectively collected corneal topographies (TMS‐4; Tomey Corporation, Nagoya, Japan) of the study group with clinically manifested keratoconus, the subclinical keratoconus group, and the control group with regular astigmatism (354 images of 206 participants).
Patient characteristics and setting
  • 170 keratoconus pictures

  • 28 subclinical keratoconus pictures (criteria based on topographic pattern and no slit‐lamp keratoconus findings)

  • 156 normal topographic pictures (from candidates for refractive surgery without any previous manifestations and with regular astigmatism)

Index tests 3 convolutional neural network models
Target condition and reference standard(s) The diagnosis of keratoconus was based on clinical signs (the existence of central protrusion of the cornea, Fleischer's ring, Vogt's striae, and focal corneal thinning on slit‐lamp examination) and topographic criteria (central K value > 47 D, I‐S value > 1.4 D, KISA% >100%, and asymmetric bowtie presentation). 4 corneas specialists classified the cases before the index test.
Flow and timing All cases were included in the reference standard and index test. All data were included in a 2 × 2 table.
Comparative Unclear whether different AI tests were developed and interpreted blind or independently and without knowledge of the results of each other. However, missing data and their causes were similar for each AI test.
Notes Supported by Grants 107L891002 and 108L891002 from National Taiwan University.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient selection
Was a consecutive or random sample of patients enrolled? No    
Was a case‐control design avoided? No    
Did the study avoid inappropriate exclusions? Unclear    
Could the selection of patients have introduced bias?   High risk  
Are there concerns that the included patients and setting do not match the review question?     High
DOMAIN 2: Index test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Unclear    
Was the model designed in an appropriate manner? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low risk  
Are there concerns that the index test, its conduct, or interpretation differ from the review question?     Low concern
DOMAIN 3: Reference standard
Is the reference standard likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and timing
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk  
DOMAIN 5: Comparative
Were different AI tests were developed and interpreted without knowledge of each other. Unclear    
Are the proportions and reasons for missing data similar for all index tests? Yes    
    Unclear risk