Kamiya 2019.
| Study characteristics | |||
| Patient Sampling | Single‐centre (Japan), retrospective case‐control study, which included a total of 304 keratoconic eyes and 239 healthy eyes (refractive surgery candidates and contact lens fitting candidates) | ||
| Patient characteristics and setting | The data of people with keratoconus who underwent corneal tomography obtained by a swept‐source anterior segment OCT (CASIA SS‐1000, Tomey, Aichi, Japan) between March 2013 and April 2018 at Miyata Eye Hospital were retrospectively reviewed. 304 keratoconic eyes with good quality scans of corneal tomography were enroled and divided according to the Amsler‐Krumeich classification, as follows.
The control group comprised 239 eyes in subjects with normal corneal and ocular findings applying for a contact lens fitting or a refractive surgery consultation. |
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| Index tests | Deep learning (convolutional neural network) of the arithmetical mean output data of 6 colour‐coded maps of an anterior segment OCT. | ||
| Target condition and reference standard(s) | Diagnosis of keratoconus was performed based on evident findings characteristic of keratoconus (e.g. corneal tomography with asymmetric bowtie pattern with or without skewed axes), and ≥ 1 keratoconus sign (e.g. stromal thinning, conical protrusion of the cornea at the apex, Fleischer's ring, Vogt's striae, or anterior stromal scar) on slit‐lamp examination. It is unclear how many corneal specialists classified the cases. However, classification was performed before inclusion. | ||
| Flow and timing | All cases were included in the reference standard and index test. All data were included in a 2 × 2 table. | ||
| Comparative | Not applicable | ||
| Notes | The study authors declared no specific grant for this research from any funding agency in the public, commercial or not‐for‐profit sectors. | ||
| 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? | Unclear | ||
| 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 | |||