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

Moreno‐Montañés 2008.

Study characteristics
Patient Sampling Healthy, ocular hypertensive and glaucoma participants were consecutively enrolled. One eye per person was randomly selected.
Patient characteristics and setting Sample size: 182 eyes of 182 participants (83 glaucoma, 40 OHT, 59 healthy controls).
Age: glaucoma patients mean (range), 68 (60 to 73) years; hypertensive 63.5 (57 to 70.5); controls 56 (47 to 67).
Sex: 87 men (45 glaucoma, 16 OHT, 26 controls) and 95 women (38 glaucoma, 24 hypertensive, 33 controls).
Ethnicity: white.
Country: Spain.
Ocular comorbidities: no corneal/retinal disease, BCVA < 20/40, spherical equivalent > ±5 D, no substantial media opacity.
Setting: Department of Ophthalmology, Clínica Universitaria de Navarra, Pamplona; Institut Catalá de la Retina, Barcelona.
Spectrum of glaucoma severity: mean (range) MD/PSD on the VF test were ‐4.94 (‐12.58 to ‐2.67)/4.29 (2.15 to 8.34) dB, for glaucoma eyes; ‐0.99 (‐2.52 to ‐0.29)/1.5(1.40 to 1.87) dB for OHT eyes.
Control participants: IOP ≤ 21 mmHg, normal VF, and no familiar glaucoma.
Index tests Confocal scanning laser ophthalmoscopy: HRT 3, software version 3.0 (Heidelberg Engineering, Dossenheim, Germany). All images were acquired after pupil dilation and were of good quality, defined as having a topographic SD of ≤ 30 μm. Contour lines were placed in the margin of the optic disk by experienced users and were reviewed by 2 authors.
No author had conflict of interest.
Target condition and reference standard(s) Manifest glaucoma: glaucomatous defects reproducible in at least 3 reliable and consecutive VFs (defined as at least 3 contiguous locations were outside the 95% normal limits of the pattern deviation plot and 1 was outside the 99% normal limits), with open angle at gonioscopy.
OHT: IOP > 21 mmHg on 3 different days, with 3 consecutive normal VFs.
Visual field testing: Humphrey Field Analyzer, 24‐2 SITA‐standard strategy (Carl Zeiss Meditec, Dublin, CA,USA). Reliability criteria included fixation losses rates, false‐positive and false‐negative rates of < 30%.
The optic disc appearance was not part of the reference standard.
Flow and timing Reference standard and index test were performed on the same day. A total of 182 eyes were enrolled. Authors stated that in 7 eyes (3 normal, 1 ocular hypertensive, 3 glaucomatous) the GPS failed to provide a sectorial classification and were excluded from the enrolled group but still 182 participants were reported and included in 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? Yes    
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? Yes    
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