Lee 2010.
Study characteristics | |||
Patient Sampling | Healthy and glaucomatous participants who met the eligibility criteria were recruited prospectively between March 2008 and March 2009. One eye per person was randomly selected. | ||
Patient characteristics and setting |
Sample size: 165 eyes of 165 participants (88 glaucoma, 77 controls). Age: glaucoma patients mean ± SD, 53.7 ± 10.8 years; controls 51.7 ± 11.4. Sex: 87 men (39 controls, 48 glaucoma), and 78 women (38 controls, 40 glaucoma). Ethnicity: Korean. Country: Korea. Ocular comorbidities: no ocular pathologies other than glaucoma, BCVA < 20/30, spherical refraction > ±5 D, cylinder refraction > ±3 D, diabetes or closed angle at gonioscopy. Setting: Asan Medical Center, Seoul. Spectrum of glaucoma severity: mean ± SD MD and PSD on the VF test were ‐6.33 ± 4.79 dB and 6.7 ± 4.12 dB, respectively. Control participants: normal optic disc appearance, normal VF result, and IOP < 22 mmHg. |
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Index tests |
Scanning laser polarimetry: GDx VCC (Carl Zeiss Meditec, Inc, Dublin, CA, USA). All images were acquired by a single well‐trained operator. The pupils were dilated if their diameter was < 3 mm. All poor‐quality scans, defined as those with a quality score grade < 8 and an atypical retardation pattern with a typical scan score of < 80 were excluded. Optical coherence tomography: Cirrus HD‐OCT, “optic disc cube” scan (Carl Zeiss Meditec, Inc, Dublin, CA, USA). All images were acquired by a single well‐trained operator. The pupils were dilated if their diameter was < 3 mm. Images with signal strength < 6, overt misalignment of the surface detection algorithm on at least 15% of consecutive A‐scans or 20% of cumulative A‐scans or overt decentration of the measurement circle location, were excluded. No details about authors' conflict of interest were reported. |
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Target condition and reference standard(s) |
Manifest glaucoma: glaucomatous VF defect (defined as a cluster of 3 points with a P < 5% on a pattern deviation map in at least 1 hemifield, including at least 1 point with a P < 1% or a cluster of 2 points with a probability of < 1% and a GHT or PSD outside 99% normal limits ) and a glaucomatous ONH appearance (vertical cup disc ratio > 0.7, or a vertical cup–disc ratio asymmetry > 0.2 between eyes, or diffuse/focal neural rim thinning or haemorrhage). Visual field testing: Humphrey Field Analyzer, 24‐2 SITA‐standard strategy (Carl Zeiss Meditec, Dublin, CA, USA). VF reliability criteria included fixation losses rates of < 20% and false‐negative and false‐positive rates of < 15%. Optic disc evaluation: stereoscopic optic nerve photography. |
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Flow and timing | The time interval between reference standard and index tests was < 2 weeks. 19 (> 10%) eyes were excluded due to poor SD‐OCT or GDx VCC quality images. | ||
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 | Unclear | ||
Could the conduct or interpretation of the index test have introduced bias? | Unclear 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? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | No | ||
Did all patients receive a reference standard | Yes | ||
Could the patient flow have introduced bias? | High risk |