Xu 2017.
| Study characteristics | |||
| Patient Sampling | Prospective, single‐centre, cross‐sectional study. People with keratoconus were enroled at the Affiliated Eye Hospital of Wenzhou Medical University in China. Complete ocular examinations were performed by 2 experienced doctors, including a review of medical and family history, corrected distance visual acuity, slit‐lamp biomicroscopy, fundus examination, and corneal topography using Medmont E300 (Medmont, Inc., Nunawading Melbourne, Australia). |
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| Patient characteristics and setting | Participants were divided into the following 3 groups.
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| Index tests | Participants were divided into a training set (normal, subclinical keratoconus group, and keratoconus group) used to build the discrimination function, and a validation set (normal and subclinical group) used to test the diagnostic power. The goal of the present study was to apply the Zernike fitting method to describe the 3D varying complexity of corneal shapes and the 3D distribution of corneal thickness, and to characterize the entire corneal topography and tomography data in subclinical eyes, keratoconus eyes, and normal eyes using Pentacam tomography. Furthermore, the metrics constructed from Zernike polynomials were compared to improve the diagnostic sensitivity and specificity for the detection of subclinical keratoconus corneas. |
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| Target condition and reference standard(s) | 2 experienced doctors performed complete ocular examinations, including a review of medical and family history, corrected distance visual acuity, slit‐lamp biomicroscopy, fundus examination, and corneal topography using Medmont E300 (Medmont, Inc., Nunawading Melbourne, Australia). | ||
| Flow and timing | The data from all participants were checked by 3 ophthalmologists. The diagnosis was made before the analysis with the AI algorithm. | ||
| Comparative | Not applicable | ||
| Notes | This study was supported by the National Natural Science Foundation of China (81400441 to Shen), the National Key Research and Development Program of China (2016YFC0102500 to Wang), and the Zhejiang provincial Natural Science Foundation of China (LQ17H120008 to Xu). | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Was a case‐control design avoided? | Unclear | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| Could the selection of patients have introduced bias? | Unclear risk | ||
| Are there concerns that the included patients and setting do not match the review question? | Unclear | ||
| 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? | 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 | |||