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. 2023 Nov 15;2023(11):CD014911. doi: 10.1002/14651858.CD014911.pub2

Kovacs 2016.

Study characteristics
Patient Sampling Retrospective, single‐centre (Hungary), case‐control study, which involved 135 eyes of people with bilateral keratoconus (keratoconus group), normal fellow eyes of people with unilateral keratoconus (fellow‐eye group), and eyes of refractive surgery candidates (control group).
Patient characteristics and setting
  • Keratoconus group: 60 eyes of 30 people with bilateral keratoconus

  • Fellow‐eye group: 15 normal fellow eyes of people with unilateral keratoconus

  • Control group: 60 eyes of 30 refractive surgery candidates

Index tests Multilayer perception classifier (neural network) trained on bilateral data of index of height decentration.
Target condition and reference standard(s) Keratoconus was diagnosed according to classic corneal biomicroscopic and topographic findings using the criteria of Rabinowitz: the existence of central protrusion of the cornea with Fleischer's ring, Vogt's striae, or both, by slit‐lamp examination in addition to the following topographic findings: a central keratometry (K) value > 47.2 D or an I‐S value > 1.4 D, or KISA% > 100%. Both eyes in the keratoconus group and the affected eye in the unilateral keratoconus group had abnormal keratoconus indices measured by a Scheimpflug camera (Pentacam HR). It is unclear who classified the cases. Classification was performed 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 OTKA NN106649 from the Hungarian Scientific Research Fund. The funder had no role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript.
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? Yes    
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? No    
Could the conduct or interpretation of the index test have introduced bias?   Unclear 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? Unclear    
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?   Unclear 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