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. 2015 Nov 30;2015(11):CD008803. doi: 10.1002/14651858.CD008803.pub2

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.
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.
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.
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