Koh 2014.
Study characteristics | |||
Patient Sampling | Case‐control study in which glaucoma patients seen by a glaucoma specialist were consecutively enrolled during the period from May 2012 to October 2012 at the glaucoma clinic at Kim’s Eye Hospital. Healthy control were recruited from among those who visited the clinic during the enrolment period for an annual health examination. One eye per person was included. | ||
Patient characteristics and setting |
Sample size: 110 eyes of 110 participants (60 glaucoma and 50 healthy controls). Age: glaucoma mean ± SD, 60.7 ± 13.9 years; controls, 58.5 ± 14.9 years. Sex: 50 men (27 glaucoma, 23 controls) and 60 women (33 glaucoma, 27 controls). Ethnicity: not reported. Clinical Setting: Glaucoma clinic at Kim’s Eye Hospital, Seul. Country: Korea. Ocular comorbidities: patients with concurrent retinal disease (i.e. secondary to a vascular disorder, macular degeneration), optic nerve disease other than glaucoma, or a brain disorder that could influence VF results, or media opacity, were excluded. Spectrum of glaucoma severity: the median (1st and 3rd quartiles) MD and PSD on the VF test were ‐7.64 (‐10.69 to ‐3.84) and 6.92 (4.75 to 8.81) respectively, for glaucomatous eyes. Control participants: IOP < 21 mmHg, normal anterior chamber and open angle, a normal ONH without glaucomatous changes; no RNFL defect on red‐free fundus photography; and normal reliable VF test results. |
||
Index tests |
Optical coherence tomography: Cirrus HD‐OCT (Carl Zeiss Meditec, Dublin, CA, USA). Optic disc cube 200 x 200 scan protocol was used for the analysis. Optical coherence tomography: Spectral OCT/scanning laser ophthalmoscopy (OPKO/OTI, Miami, FL, USA). Scan circle centred on the optic disc. All images had to have signal strength ≥ 6 and no motion artefacts. The authors report no conflicts of interest. |
||
Target condition and reference standard(s) |
Manifest glaucoma: normal anterior segment on slit‐lamp examination, glaucomatous ONH appearance (increased cup‐disc ratio and narrowing of the neuroretinal rim), RNFL defects on red‐free fundus photography(dark wedge‐shaped area with its apex touching the optic disc border in the brightly‐striated pattern of the surrounding RNFL or a generalised loss of RNFL visibility in the upper or lower retina) and glaucomatous VF defects (a cluster of 3 points with P < 5% on the PD map in at least 1 hemifield, including at least 1 point with P < 1% or a cluster of 2 points with P < 1%, or GHT outside normal limits, or a PSD with P < 5%). Visual field test: Humphrey Field Analyzer (Carl Zeiss Meditec); 24‐2 SITA–standard strategy. All exams had fixation losses and false‐positive and false‐negative rates of < 15%. |
||
Flow and timing | No details about exclusion were reported. The index and reference test were performed on the same day |
||
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 |