Kim 2014b.
Study characteristics | |||
Patient Sampling | Retrospective case‐control study including early glaucoma, preperimetric glaucoma and healthy controls. If both eligible, one eye per person was randomly selected. | ||
Patient characteristics and setting |
Sample size: 204 eyes of 204 participants (72 early glaucoma, 68 preperimetric glaucoma, 64 normal controls) Age: early glaucoma mean ± SD, 56.83 ± 12.73 years; preperimetric glaucoma, 53.12 ± 10.69 years; controls, 51.77 ± 14.44 years; Sex: not reported. Ethnicity: not reported. Setting: general healthcare clinic or glaucoma clinic of the Guri Hanyang University Medical Center from September 2011 through May 2013. Country: South Korea. Ocular comorbidities: patients with co‐existing retinal disease, uveitis, or non‐glaucomatous optic disc neuropathy were excluded. Spectrum of glaucoma severity: the mean ± SD MD and PSD on the VF test were ‐3.08 ± 1.61 and 4.29 ± 2.64 respectively, for early glaucoma; ‐1.02 ± 1.29 and 1.87 ± 0.5 respectively for preperimetric glaucoma. Control participants: first‐degree relatives with glaucoma, no history or evidence of intraocular surgery, IOP < 22 mmHg, a normal optic disc appearance and ophthalmic findings. |
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Index tests |
Optical coherence tomography: Cirrus OCT (Carl Zeiss Meditec, Dublin, CA, USA); software version 6.0. Poor‐quality OCT images such as those with low signal strength (< 70), motion artefact, or decentration were excluded. 7 x 7 mm scanning disc protocol was used to analyse RNFL and GCC parameters. The authors declare no conflict of interest |
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Target condition and reference standard(s) |
Manifest perimetric glaucoma: glaucomatous VF results (defined as a cluster of 3 points with P < 5% on the pattern deviation map in at least 1 hemifield, including at least 1 point with P < 1%; or a cluster of 2 points with P < 1%, and GHT or PSD outside normal limits) and glaucomatous ONH/RNFL appearance (neuroretinal rim loss or notching, focal thinning of the NFL, disc haemorrhages, or vertical elongation of the optic cup). Manifest preperimetric glaucoma: glaucomatous ONH/RNFL appearance (neuroretinal rim loss or notching, focal thinning of the NFL, disc haemorrhages, or vertical elongation of the optic cup) with normal VF results. Visual field test: Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA, USA) 30‐2 SITA standard programme. The fixation losses < 20 %, and false‐positive and false‐negative errors < 15 %, were considered as reliable. Optic disc/RNFL evaluation: dilated funduscopy using a 78‐D lens and stereoscopic optic disc photography. |
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Flow and timing | No details reported about exclusion and time interval between index and reference test. | ||
Comparative | |||
Notes | None. | ||
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? | No | ||
Did the study avoid inappropriate exclusions? | Yes | ||
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) | |||
If a threshold was used, was it pre‐specified? | Yes | ||
Were imaging test's quality assessed? | Yes | ||
Were any conflict of interest avoided | 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 standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
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 | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Unclear | ||
Did all patients receive a reference standard | Yes | ||
Could the patient flow have introduced bias? | Unclear risk |