Sunday, May 28, 2023
| Study | Description | Major exclusions | Participants | Sensitivity/Specificity |
|---|---|---|---|---|
| Bagchi et al. 2019[26] | Retrospective audit of patients who presented to a retinal clinic in the United Kingdom with high myopia (<−6D or AL > 26 mm) and new onset visual disturbance who received FA, OCTA and SD-OCT imaging. | Excluded patients who did not receive all three imaging modalities. Excluded patients with poor quality images. Excluded patients with other co- existing major ocular conditions. | 27 eyes of 26 patients (18 female, 6 male) Mean age 47.7 ± 19.7 years | OCTA vs FA: Sensitivity 19/23, specificity 3/4 SD-OCT vs FA: Sensitivity 23/23, specificity 0/4 |
| Milani et al.[24] | Retrospective audit of patients seen at a research hospital in Italy with recent vision deterioration, pathologic myopia (<−6D and staphyloma) and suspected mCNV who received near infrared, autofluorescence, FA and SD-OCT imaging at first presentation. | Excluded patients who did not receive all four imaging modalities. Excluded patients with poor quality images. Excluded patients who had previous vitreoretinal surgery, diabetes, signs of age-related macular degeneration, or vitreoretinal interface-related pathologies. | 65 eyes of 62 patients (44 female, 21 male) Mean age 66.72 years, range 18–89 Mean refraction −9.72D, range −6 to −22 | SD-OCT vs FA: Sensitivity 48/49, specificity 16/16 |
| Miyata et al. 2016[25] | Prospective study of consecutive patients who presented to a university ophthalmology clinic in Japan with pathologic myopia (<−6D or AL > 26 mm, plus chorioretinal abnormalities) and treatment naïve exudative lesions. | Patients with OCTA images of insufficient quality were excluded from analysis. | 28 eyes of 26 patients (22 female, 4 male) Included in analysis: 21 eyes of 20 patients (17 female, 3 male) Mean age 63.0 ± 13.6 years | OCTA vs FA: Sensitivity 16/17, specificity 4/4 |
| Querques et al. 2017[28] | Retrospective audit of patients who presented to a university hospital’s retinal clinic in Italy with pathologic myopia (<−8D or AL > 26.5 mm, plus characteristic degenerative changes of the sclera/ choroid/retina) who were diagnosed with mCNV using FA.a An additional cohort of patients with pathologic myopia and no evidence of mCNV were enrolled as a negative control group. | Excluded patients with co-existing retinal conditions, history of ocular inflammation in the study eye, significant media opacities, or large haemorrhage. Patients with OCTA images of insufficient quality or who did not have FA performed on the same day as OCTA were excluded from analysis. Negative control group: Excluded patients with co- existing retinal conditions, or previous ocular treatments in the study eye. | 36 eyes of 28 patients (23 female, 5 male) Included in analysis: 21 eyes of 17 patients (14 female, 3 male) Mean age 57.8 ± 14.5 years= Negative control group: 32 eyes of 32 patients (27 female, 5 male) Mean age 56.2 ± 14.4 years, range 26–84 | OCTA vs FAa: Sensitivity 19/21, specificity 30/32 |
| Su et al. 2014[27] | Prospective study of patients who presented to a macular service centre in China with high myopia (< −6D and AL > 26.5 mm) and myopic maculopathy. | Excluded patients with other retinal or choroidal diseases, or dense cataracts. | 69 eyes of 42 patients (23 female, 19 male) Mean age 47.3 ± 17.3 years, range 20–79 | SD-OCT vs FA: Sensitivity 16/16, specificity 53/53 |
Table 1. Key details of included studies.
D Dioptres, AL Axial length, FA Fluorescein angiography, OCTA Optical coherence tomography angiography, SD-OCT Spectral domain optical coherence tomography, mCNV Myopic choroidal neovascularisation.
aUse of FA as reference standard was clarified by direct communication with the corresponding author.
| Outcome (95% CI) | Outcome (95% CI) | |||||
|---|---|---|---|---|---|---|
| OCTA compared to FA | ||||||
| Individual studiesa | TP | FP | FN | TN | Sensitivity | Specificity |
| Bagchi 2019 | 19 | 1 | 4 | 3 | 0.83 (0.61–0.95) | 0.75 (0.19–0.99) |
| Miyata 2016 | 16 | 0 | 1 | 4 | 0.94 (0.71–1.00) | 1.00 (0.40–1.00) |
| Querques 2017 | 19 | 2 | 2 | 30 | 0.90 (0.70–0.99) | 0.94 (0.79–0.99) |
| Pooled results from meta-analysisb | Sensitivity | Specificity | ||||
| 0.89 (0.78–0.94) | 0.93 (0.79–0.98) | |||||
| LR of a positive test | LR of a negative test | |||||
| 11.8 (3.96–35.25) | 0.12 (0.061–0.25) | |||||
| Positive PV | Negative PV | |||||
| 0.95 (0.79–0.99) | 0.85 (0.61–0.94) | |||||
| SD-OCT compared to FA | ||||||
| Individual studiesa | TP | FP | FN | TN | Sensitivity | Specificity |
| Bagchi 2019 | 23 | 4 | 0 | 0 | 1.00 (0.85–1.00) | 0.00 (0.00–0.60) |
| Milani 2016 | 48 | 0 | 1 | 16 | 0.98 (0.89–1.00) | 1.00 (0.79–1.00) |
| Su 2014 | 16 | 0 | 0 | 53 | 1.00 (0.79–1.00) | 1.00 (0.93–1.00) |
| Pooled results from meta-analysisb | Sensitivity | Specificity | ||||
| 0.99 (0.91–1.00) | unestimatable | |||||
| LR of a positive test | LR of a negative test | |||||
| unestimatable | 0.01 (0.001–0.095) | |||||
| Positive PV | Negative PV | |||||
| unestimatable | unestimatable | |||||
Table 2. Test accuracy of individual studies and pooled results from meta-analysis.
CI confidence interval, OCTA optical coherence tomography angiography, FA fluorescein angiography, TP true positive, FP false positive, FN false negative, TN true negative, LR likelihood ratio, PV predictive value, SD-OCT spectral domain optical coherence tomography.
aCalculated using RevMan Ver 5.4.1.
bCalculated using SAS macro MetaDAS v1.3.
|
Test |
Recommendation |
|---|---|
|
OCTA |
Conditionally recommend the use of OCTA to achieve a diagnosis when mCNV is clinically suspected. Statement was conditional because all studies excluded patients from analysis due to image quality issues.
|
|
SD-OCT |
Conditionally suggest clinicians may consider the use of SD-OCT to achieve a diagnosis when mCNV is clinically suspected. Statement was conditional because of the inability to estimate a pooled specificity for SD-OCT resulting in an unknown false positive rate.
|
|
OCTA + SD-OCT |
Clinicians may consider using SD-OCT if an OCTA image of sufficient quality cannot be acquired.
|
Table 3. Key recommendations.
OCTA Optical coherence tomography angiography, mCNV Myopic choroidal neovascularisation, FA Fluorescein angiography, SD-OCT Spectral domain optical coherence tomography.
Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™
This activity is intended for ophthalmologists and other clinicians caring for patients with myopic choroidal neovascularization (mCNV).
The goal of this activity is for learners to be better able to describe the test accuracy of optical coherence tomography angiography (OCTA) and spectral domain (SD)-OCT in diagnosing mCNV compared with the reference standard, fluorescein angiography, according to a meta-analysis with primary outcome of pooled sensitivity and specificity and additional outcomes of pooled likelihood ratios and patient-oriented outcomes.
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BACKGROUND/OBJECTIVES: The purpose of this project was to systematically review and meta-analyse studies assessing the diagnostic accuracy of optical coherence tomography angiography (OCTA) and optical coherence tomography (OCT) for myopic choroidal neovascularisation (mCNV). Fluorescein angiography (FA) was accepted as the reference standard.
METHODS: PUBMED and EMBASE were searched from inception to March 2021 for studies evaluating the test accuracy of OCTA and/or OCT for diagnosing mCNV. The Preferred Reporting Items for Systematic Reviews and Meta-analyses of Diagnostic Test Accuracy Studies guideline was followed, and the Grading of Recommendations, Assessment, Development and Evaluation approach was used to frame clinical recommendations. Pooled estimates of test accuracy were obtained using a bivariate model.
RESULTS: Of 410 studies assessed for eligibility, 3 studies were identified that compared OCTA to FA and 3 studies were identified that compared spectral domain (SD) OCT to FA. All studies had at least one major methodological flaw leading to an overall high risk of bias. On meta-analysis, the pooled sensitivity of OCTA was 0.89 (95% CI 0.78–0.94) and pooled specificity was 0.93 (95% CI 0.79–0.98). The pooled sensitivity of SD-OCT was 0.99 (95% CI 0.91–1.00). Due to uncertainty in individual studies, the pooled specificity of SD-OCT could not be estimated.
CONCLUSIONS: OCTA can reliably diagnose mCNV in clinically suspected patients, however, SD-OCT may not reliably establish a positive diagnosis of mCNV. Future large, prospective studies with improvements in conduct and reporting are needed to strengthen these clinical recommendations.
Approximately 166 million people around the world have myopic macular degeneration[1]. During their lifetime, up to 11.3% of these people will develop sight-threatening myopic choroidal neovascu- larisation (mCNV)[2]. Due to the progressive natural history of mCNV and time-dependent nature of vision restoration using anti-vascular endothelial growth factor treatments, there is an urgent need to understand how innovative imaging technologies can be used to facilitate early and accurate diagnosis of mCNV[2, 3].
Fluorescein angiography (FA) is the current reference standard for diagnosing mCNV[4]. However, FA is an invasive technique[5] and causes adverse systemic reactions in 4.8% of patients, with life-threatening anaphylaxis occurring in up to 0.3% of all patients[6, 7]. Optical coherence tomography angiography (OCTA) and optical coherence tomography (OCT) represent quicker and safer imaging technologies that do not require systemic dye injection, thus avoiding FA’s associated complications[4]. Whilst multiple comprehensive reviews have described the potential value of using OCTA and/or OCT for the diagnosis of mCNV[4, 5, 8, 9], we are unaware of any studies that have undertaken a meta-analysis to assess overall pooled diagnostic test accuracy.
The primary purpose of this study was to conduct a systematic review and meta-analysis to determine the test accuracy of OCTA and OCT in diagnosing mCNV compared to the reference standard, FA. The primary outcome for meta-analysis was pooled sensitivity and specificity. Pooled likelihood ratios were also estimated, and eligible studies were assessed to determine if direct measures of health consequences (patient-oriented outcomes) could be considered.
