Ruiz 2017.
| Study characteristics | |||
| Patient Sampling | Retrospective, case‐control study including 131 eyes from 102 people during routine clinical practice at the Rothschild Foundation in the period between October 2015 and January 2016. | ||
| Patient characteristics and setting | Participants were grouped as follows.
All participants had a complete ophthalmic evaluation that consisted of manifest refraction, slit‐lamp examination, and corneal tomography evaluation by both Pentacam HR and Orbscan IIz. Exclusion criteria: a history of ocular surgery (apart from laser correction in the refractive surgery group), corneal cross‐linking, and very advanced keratoconus with corneal scarring. Rigid contact lens wearers were asked to remove their lenses at least 1 week before testing. |
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| Index tests | The support vector machine uses 25 topography and tomography parameters of the anterior and posterior corneal surfaces from the Pentacam. The algorithm automatically classifies corneal patterns and shows the probability that the cornea has keratoconus, forme fruste or suspect keratoconus, photorefractive surgery, normal, or regular astigmatism. | ||
| Target condition and reference standard(s) | Participants were clinically diagnosed at the Rothschild Foundation based on slit‐lamp examination and corneal topography and classified into 4 groups. Topography and tomography were measured with the Pentacam HR and the Orbscan IIz. Participants were diagnosed before the corneal images were analysed with the algorithm. | ||
| Flow and timing | It was unclear whether all participants received the same reference standard. All data were included in a 2 × 2 table. | ||
| Comparative | Not applicable | ||
| Notes | Supported by a research grant of the Flemish government agency for Innovation by Science and Technology (grant nr. IWT/110684). | ||
| 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? | 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? | Unclear | ||
| 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 | |||