Arintawati 2013.
Study characteristics | |||
Patient Sampling | Retrospective study in which new glaucoma and glaucoma‐suspect patients, referred to the Department of Ophthalmology, between March 2008 and April 2011, were recruited. 164 patients were studied. 261 eyes were included in the analysis. | ||
Patient characteristics and setting |
Sample size: 261 eyes included in the analysis (80 advanced glaucoma, 81 early glaucoma, 32 preperimetric glaucoma and 68 controls). Age: glaucoma mean ± SD, 61.49 ± 14.21 years (advanced glaucoma 64.56 ± 10.89; early glaucoma 60.16 ± 16.77; preperimetric glaucoma 58.94 ± 12.15 years); controls 59.65 ± 16.88 years. Sex: 113 men and 150 women Ethnicity: not specified. Setting: Department of Ophthalmology, Hiroshima University Hospital. Country: Japan. Ocular comorbidities:patient with refractive errors (spherical equivalent) > +3.00 D or < 7.00 D, and those with retinal disease that could cause VF defects or optic disc abnormalities were excluded. Spectrum of glaucoma severity: The mean ± SD mean deviation and PSD on the VF test were –6.05 ± 6.22 and 6.57 ± 4.88 for glaucoma group overall (‐0.11 ± 1.55 and 1.58 ± 0.31 respectively for the preperimetric eyes, ‐2.68 ± 1.79 and 4.03 ± 2.57 respectively for the early glaucoma, ‐11.99 ± 5.29 and 11.26 ± 3.47 respectively for advanced glaucoma). Control participants: IOP < 22 mmHg, normal optic disc appearance, and normal ophthalmological findings. |
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Index tests | RTVue Fourier‐domain OCT system (OptovueInc., Fremont, CA, USA); software version 4.0.5.100). Imaging was performed using GCC and RNFL 3.45 mode analysis. Images with misalignment of the surface detection algorithm, or decentration of the measurement circle and the signal strength index < 40, were excluded. The authors indicate no financial conflict of interest. |
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Target condition and reference standard(s) |
Manifest glaucoma: VF defects (defined as the pattern deviation plot with more than 3 contiguous points with P < 0.05 and at least 1 with P < 0.01 level on the same side of the horizontal meridian and GHt outside the normal limit) and glaucomatous optic disc appearance (neuroretinal rim loss, notching, focal thinning of the nerve fibre layer, disc haemorrhages, or vertical elongation of the optic cup). Preperimetric Glaucoma: glaucomatous optic disc appearance but normal VF results. Visual field test: Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA, USA); 24‐2 SITA–standard strategy. Optic nerve evaluation: Dilated fundus biomicroscopy. |
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Flow and timing | 164 patients were originally studied. Patients with SD‐OCT not good were excluded from this study. 261 eyes were included in the analysis, but details about number of exclusions were not reported. Time interval between reference standard and index tests was not reported. |
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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 |