Kim 2011.
Study characteristics | |||
Patient Sampling | Glaucoma patients with or without high myopia were consecutively enrolled from January 2009 to June 2009. Normal controls were sequentially matched. One eye per person was randomly selected. | ||
Patient characteristics and setting |
Sample size: 196 participants examined, 150 included in the analysis. The participants were divided into 2 groups: a highly‐myopic group (spherical equivalent < ‐6.00 D) and a non‐highly myopic group (spherical equivalent > ‐6.00 D): 45 highly‐myopic participants (21 glaucoma, 24 controls) and 105 non‐highly myopic (56 glaucoma, 49 controls). Age: glaucoma highly‐myopic eyes mean ± SD, 42.67 ± 16.32 years; highly‐myopic controls 41.83 ± 12.44 years; glaucoma non‐highly myopic eyes mean ± SD, 56.02 ± 14.90 years; non‐highly myopic controls 52.39 ± 15.55 years; Sex: 76 men (45 glaucoma, 31 controls) and 74 women (32 glaucoma, 42 controls). Ethnicity: Asian. Country: Korea. Setting: Glaucoma‐Cataract Clinic of Severance Hospital, Seoul. Ocular comorbidities: highly‐myopic eyes with any atypical non‐glaucomatous field defect and eyes with a narrow angle, media opacity, prior history of ocular surgery, diabetes mellitus, or other diseases affecting the VF were excluded. Spectrum of glaucoma severity: the mean ± SD MD and PSD on the VF test were ‐8.56 ± 5.82 dB and 7.85 ± 4.76 dB respectively, for glaucoma highly‐myopic eyes; were ‐9.49 ± 7.41 dB and 7.75 ± 4.16 dB, respectively for glaucoma non‐highly myopic eyes. Control participants: IOP < 21 mmHg, normal appearance of ONH and normal VF test result. |
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Index tests | Optical coherence tomography: RTVue‐100 (software version: 4.0.5.39, Optovue, Fremont, CA, USA). The nerve head map 4 mm diameter (NHM4) and the MM7 scanning protocols were used. Images with a poor quality (SSI < 35, overt misalignment of the surface detection algorithm or overt decentration of the measurement circle location) were excluded. No authors had conflict of interest. | ||
Target condition and reference standard(s) |
Manifest glaucoma: glaucomatous VF defects (defined as having 3+ significant (P < 0.05) non‐edge contiguous points with at least 1 at the P < 0.01 level on the same side of the horizontal meridian in the pattern deviation plot, classified as outside normal limits in the GHT) and glaucomatous appearance of the ONH not otherwise described. Visual field testing: Humphrey Field Analyzer, 20‐2 SITA standard programme (Carl Zeiss Meditec). VF reliability criteria were not reported. Optic disc and RNFL evaluation: stereoscopic optic disc photography or red‐free RNFL photography. |
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Flow and timing | Index test and reference standard were performed on the same day. 46 eyes (> 10%) were excluded from the final analysis: 36 because of poor OCT image (low signal strength (11), improper scan decentration (14), presence of epiretinal membrane (2), erroneous RNFL or GCC profile (5) algorithm of the GCC failure(4)); 3 because of unacceptable stereoscopic fundus photography, and 7 due to unreliable VF. | ||
Comparative | |||
Notes | This research was supported by the Basic Science Research Programme through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology (No 2009‐0076736). | ||
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? | No | ||
Did all patients receive a reference standard | Yes | ||
Could the patient flow have introduced bias? | High risk |