Aptel 2010.
Study characteristics | |||
Patient Sampling | Prospective investigation conducted in a French university‐affiliated glaucoma centre. 166 patients were initially screened. One eye from each of 120 patients were finally included in the analysis: 40 with glaucoma, 40 with suspected glaucoma, and 40 healthy participants. | ||
Patient characteristics and setting |
Sample size: 166 patients initially screened, 120 eyes of 120 patients included in the analysis (40 glaucoma, 40 suspected glaucoma, 40 controls). Age: glaucoma patients mean ± SD, 63.4 ± 11.2 years; suspected glaucoma 61.7 ± 12.7 years; controls 60.9 ± 13.1. Sex: 46 men (14 glaucoma, 15 suspected glaucoma, 17 controls) and 74 women (26 glaucoma, 25 suspected glaucoma, 23 controls). Ocular comorbidities: no retinal disease, BCVA < 20/40, SE < ‐6 or > +3 D, non‐glaucomatous optic neuropathy or intraocular surgery except for uncomplicated cataract surgery. Setting: French university‐affiliated glaucoma centre. Country: France. Spectrum of glaucoma severity: mean ± SD MD and PSD on the VF test were ‐9.88 ± 6.93 dB and 4.42 ± 4.85 dB for glaucoma, ‐1.73 ± 2.16 dB and 2.06 ± 0.54 dB for suspected glaucoma. Control participants: IOP < 22 mmHg, normal optic disc appearance and no repeatable abnormal SAP results. |
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Index tests |
Scanning laser polarimetry: GDx VCC, software version 5.5.0 (Carl Zeiss Meditec, Inc.). Only well‐focused, well‐centred images with a quality scan score >8 were used. Optical coherence tomography: Cirrus OCT, software version 3.0 (Carl Zeiss Meditec, Inc, Dublin, California, USA). Imaging was performed using the 200 x 200 protocol optic disc cube. Only well‐focused, well‐centred images, without eye movement and with a signal strength of 7/10 or more, were used. The authors indicate no financial conflict of interest. |
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Target condition and reference standard(s) |
Manifest glaucoma: abnormal SAP result (GHT and PSD outside 95% of normal limits), and optic nerve damage (asymmetric cup‐to‐disc ratio > 0.2, rim thinning, notching, excavation, or RNFL defect). Suspected glaucoma: glaucomatous optic nerve damage (asymmetric cup‐to‐disc ratio > 0.2, rim thinning, notching, excavation, or retinal nerve fibre layer defect) without repeatable abnormal SAP results. Visual field testing: Humphrey Field Analyzer, 24‐2 SITA–standard strategy (Zeiss‐Humphrey Systems, Dublin, CA, USA). Optic disc evaluation: dilated fundus was examined by indirect ophthalmoscopy. |
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Flow and timing | Time interval between reference standard and index tests was not reported. 14 patients were excluded from the analysis for poor OCT quality criteria, 23 for poor GDx VCC quality criteria, and 28 for poor VF quality or reliability criteria. | ||
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 | 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? | Unclear | ||
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 |