Friday, September 22, 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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Literature search and study selection
The primary literature search identified 410 abstracts of potentially eligible studies. Review of retrieved abstracts and hand-searchingof reference lists resulted in 50 articles for full text evaluation, of which five were deemed eligible for inclusion[24–28]. Figure 1 reports the study selection flow. (Supplement eTable 2) provides additional details regarding studies deemed ineligible.
Amongst the five studies identified as being on-topic, two evaluated OCTA[25, 28], two evaluated spectral domain (SD) OCT[24, 27], and one conducted evaluations of OCTA and SD-OCT[26]. The three studies assessing test accuracy of OCTA reported complete data on a total of 95 participants (101 eyes)[25, 26, 28], whilst the three studies evaluating SD-OCT reported complete data on 130 participants (161 eyes)[24, 26, 27]. Mean (standard deviation) age was 55.90 (7.71) years in the OCTA studies and 53.91 (11.10) years in the SD-OCT studies. Additional details of the studies are reported in Table 1. (Supplement eTable 3) reports detailed descriptions of the index and reference test assessment procedures.
Risk of bias assessment
All five included studies were found to have at least one major methodological flaw leading to a potential high risk of bias. Two of the five studies were assessed as high risk of bias in five out of seven bias scoring domains[24, 26]. One study was assessed as high risk of bias in four out of seven bias scoring domains[28]. One study was assessed as high risk of bias in two out of seven bias scoring domains[27], whilst the remaining study was rated high risk of bias in one of the seven bias scoring domains[25]. See Fig. 2 for complete details of the risk of bias assessment.
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EnlargeFigure 2. Risk of bias assessment of included studies. Low risk of bias, Unclear risk of bias, High risk of bias
Based on a priori defined criteria [13], publication bias could not be assessed due to the inadequate number of included studies.
Primary analysis: test accuracy
Studies comparing OCTA with FA. Three studies enrolling 95 patients (101 eyes) compared the performance of OCTA against FA [25, 26, 28]. Pooled diagnostic performance showed a sensitivity of 0.89 (95% CI 0.78–0.94) and specificity of 0.93 (95% CI 0.79–0.98). The likelihood ratio of a positive test result was 11.8 (95% CI 3.96–35.25) and the likelihood ratio of a negative test result was 0.12 (95% CI 0.061–0.25).
Studies comparing SD-OCT with FA. Three studies enrolling 130 patients (161 eyes) compared the performance of SD-OCT against FA [24, 26, 27]. Pooled diagnostic performance showed a sensitivity of 0.99 (95% CI 0.91–1.00). The likelihood ratio of a negative test result was 0.01 (95% CI 0.001–0.095). Pooled specificity and the likelihood ratio of a positive test result were unestimatable.
Additional information such as sensitivity and specificity for individual studies, pooled positive predictive value and pooled negative predictive value for each comparison (OCTA vs FA and SD- OCT vs FA) are reported in Table 2.
Sources of heterogeneity
Studies comparing OCTA with FA. With only three studies, a priori identified potential sources of heterogeneity could not be investigated.
Studies comparing SD-OCT with FA. With only three studies, a priori identified potential sources of heterogeneity could not be investigated.
To investigate whether individual study inconsistencies prevented convergence towards a pooled estimate of specificity, meta-analysis was repeated with the study by Bagchi et al. [26] removed. Reanalysis including results from the studies by Su et al. [27] and Milani et al. [24] also failed to converge on a pooled estimate of specificity; see Supplement eTable 4.
Downstream consequences
No studies provided a head-to-head comparison of the downstream consequences (e.g. management decisions, health outcomes, resource utilisation) of using OCTA or SD-OCT to diagnose mCNV compared to using the reference standard, FA.
Clinical recommendations
Given an overall moderate certainty of the evidence, we conditionally recommend the use of OCTA to achieve a diagnosis when mCNV is clinically suspected. With moderate confidence in the consistency of the estimate of sensitivity between studies and moderate confidence in the precision of the pooled estimate of sensitivity, we recommend OCTA as an initial test to rule out mCNV. With moderate confidence in the consistency of the estimate of specificity between studies and moderate confidence in the precision of the pooled estimate of specificity, we also recommend OCTA to rule in the presence of mCNV. However, as indicated by the wide confidence intervals around the likelihood ratios for a positive test result and a negative test result (Table 2), OCTA may have high false positive and false negative rates.
Given an overall low to moderate certainty of the evidence, we conditionally suggest clinicians may consider the use of SD-OCT to achieve a diagnosis when mCNV is clinically suspected. With high confidence in the consistency of the estimate of sensitivity between studies and high confidence in the precision of the pooled estimate of sensitivity, we recommend SD-OCT as an initial test to rule out mCNV. However, with low confidence in the consistency of the estimate of specificity between studies and an unestimatable pooled specificity, we do not recommend reliance on SD-OCT alone to rule in the presence of mCNV because the false positive rate is unknown.
Complete results of the judgements on the certainty of the evidence [11, 12] are reported in Supplement eFig. 1 and eTable 5. Clinical Guidance Recommendations are summarised in Table 3. (Supplement eTable 3) reports complete eligibility criteria used by each study to identify patients who were clinically suspected to have mCNV.
