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

Maeda 1995a.

Study characteristics
Patient Sampling Single‐centre, case‐control study. Corneal topographic maps of the TMS‐1 were drawn from the Louisiana State University Eye Center patient population.
Patient characteristics and setting Maps from 176 eyes of 125 people were selected and grouped as follows.
  • 44 with topographic features typical of keratoconus

  • 132 with topographic features typical of a variety of non‐keratoconus conditions (normal, with‐the‐rule‐astigmatism, contact lens‐induced warpage, excimer laser photorefractive keratectomy, penetrating keratoplasty, and pellucid marginal degeneration).


Maps of eyes with keratoconus were selected from the charts of people previously diagnosed as having keratoconus in our clinic.
Index tests Combined discriminant analysis and classification tree, based on topographic images. The algorithm determined whether a keratoconus‐like pattern was seen in a particular map in the binary classification tree and, if so, reported a value between 5% and 95% in proportion to the linear discriminant function to quantify the severity of the keratoconus pattern.
Target condition and reference standard(s) Topography images were made with the TMS‐1. It is unclear who diagnosed the cases; however, the diagnosis was made before the algorithm analysed the images.
Flow and timing It is unclear whether all eyes were diagnosed with the same reference standard. All data were included in a 2 × 2 table.
Comparative Not applicable
Notes This study was supported in part by US Public Health Service grants EY03311 and 02377 from the National Eye Institute, National Institutes of Health, Bethesda, Md; an unrestricted departmental grant from Research to Prevent Blindness Ine, New York, NY; and funds from Computed Anatomy Ine, New York, NY, and Menicon Co, Ltd, Nagoya, Japan. The Conecare data analysis software used in this study was provided courtesy of Yaron S. Rabinowitz, MD.
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? 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? Unclear    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Unclear risk  
DOMAIN 5: Comparative