Carvalho 2005.
Study characteristics | |||
Patient Sampling | Retrospective, single‐centre case‐control study. 80 corneal maps were selected from the database of the EyeSys System 2000 (EyeSys Vision, Houston, TX) topographer in Brazil. | ||
Patient characteristics and setting | 80 corneal maps of different people were selected according to the following 5 categories (16 corneas for each category).
Criteria for diagnosis of keratoconus are unclear. Corneal maps had few or no nose or eyelid shadows; only the right eye of each person was allowed. Right and left eyes of the same person were not used. The investigators excluded corneas with incipient keratoconus, keratoconus with high degrees of symmetrical astigmatism, and other cases for which a single prevailing diagnosis could not be issued. In the case of regular profiles, given that even the most symmetrical corneas have some degree of with‐the‐rule astigmatism, only corneas with simulated keratometry 0.25 D were considered "regular" or "normal." |
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Index tests | A neural network which used the first 15 Zernike coefficients | ||
Target condition and reference standard(s) | The selection and classification were performed by 2 eye care specialists, with unclear criteria. However, cases were classified before inclusion. | ||
Flow and timing | All cases were included in the reference standard and index. All data were included in a 2 × 2 table. | ||
Comparative | Not applicable | ||
Notes | Supported in part by FAPESP (São Paulo Research Foundation) process #03132–8. | ||
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? | No | ||
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? | Yes | ||
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 |