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. |
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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. |
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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. |
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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 |