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

Mai 2007.

Study characteristics
Patient Sampling Healthy controls and glaucoma patients were recruited. Controls were recruited consecutively either from an ongoing longitudinal follow‐up study or from staff members, their friends and spouses, partners of the patients, or volunteers. No details on glaucoma patient selection method. One eye per person was randomly selected.
Patient characteristics and setting Sample size: 133 eyes of 133 participants (92 glaucoma, 41 controls).
Age: glaucoma patients mean ± SD, 65.4 ± 10.9 years; controls 61.2 ± 12.0.
Sex: 73 men, 60 women.
Ethnicity: white.
Country: Netherland.
Ocular comorbidities: no ocular disease other than glaucoma, BCVA < 20/40, spherical refraction < ‐7 D or > +3 D, intraocular surgery (except uncomplicated cataract surgery), diabetes mellitus or arterial hypertension.
Setting: Rotterdam Eye Hospital, Rotterdam.
Spectrum of glaucoma severity: mean ± SD of MD and PSD on the VF test for glaucoma were –9.4 ± 7.4 dB and 8.1 ± 3.9 dB, respectively. According to Hodapp et al. grading score 59 eyes had mild and moderate glaucoma, 33 severe.
Control participants: IOP < 21 mmHg, normal VF results (MD and PSD within 95% confidence limits and GHT within normal limits ) and healthy‐appearing ONH (no diffuse/local rim thinning, cupping, or optic disc haemorrhages).
Index tests Scanning laser polarimetry: GDx VCC, software version 5.4.0, GDx‐ECC, software version 5.5.0.11 (Carl Zeiss Meditec, Inc., Dublin, CA, USA). Images were acquired through undilated pupils, by 2 trained and experienced technicians following a standard protocol. Only images of high quality (with quality scan score ≥ 7 ) were selected.
Some authors had conflict of interest.
Target condition and reference standard(s) Manifest glaucoma: glaucomatous optic disc appearance (diffuse or local rim thinning or cupping), abnormal VF result (confirmed on 2 consecutive occasions and defined as 2 or more adjacent points at a P ≤ 0.01 level, or 3+ adjacent points at a P ≤ 0.05 level in the total deviation plot, or GHT outside normal limits) and open angle by gonioscopy.
Visual field testing: Humphrey Field Analyzer, full threshold strategy (126 eyes), 24‐2 SITA standard strategy (5 eyes), or 24‐2 SITA‐fast (2 eyes) (Carl Zeiss Meditec, Inc.). Reliability criteria included fixation losses rates of < 25% and false‐positive rates of < 20%. Acceptable false‐positive rate was < 20% and < 33% for controls and glaucoma respectively.
Flow and timing The time interval between reference standard and index test was not reported. No patients were reported by the authors as excluded from the analysis.
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 No    
Could the conduct or interpretation of the index test have introduced bias?   High 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? Yes    
Did all patients receive a reference standard Yes    
Could the patient flow have introduced bias?   Unclear risk