Criteria for the reliability of optical coherence tomography measurements in patients with age-related cataract

Purpose. To determine optimal criteria for reliable optical coherence tomography (OCT) measurements in patients with age-related cataract. Material and methods. We examined 83 patients (83 eyes) with agerelated cataract before and after cataract surgery. The intensity of lens opacity was assessed by the Cirrus HD-OCT signal strength and Pentacambased Scheimpflug images analysis. Clinical cataract grading was performed according to the WHO classification. Preoperative measurement was considered reliable if its' difference with postoperative measurement did not exceed 5 ?m for the peripapillary retinal nerve fiber layer thickness (pRNFL) and 8 ?m for the central subfield thickness. Results. According to the ROC analysis, only the OCT signal strength allows to distinguish reliable OCT measurements: area under the ROC-curve (AUC) of the OCT signal strength was 0.815 (95% confidence interval 0.720–0.909) for the pRNFL and 0.756 (95% CI: 0.632–0.880) for the central subfield thickness. The best signal strength thresholds for reliable data were 5.5 for pRNFL and 4.5 for the central macular thickness (considering that the signal strength is measured in integers, these values should be rounded to 6 and 5 respectively). The rest of the studied parameters had AUC less than 0.6 so they cannot be used for evaluating OCT data. Conclusion. In patients with age-related cataract, only OCT signal strength can determine reliability of the OCT measurements. The lowest signal strength for reliable data on the Cirrus HD-OCT is 6 for pRNFL and 5 for centr al subfield thickness. Key words: optical coherence tomography, cataract, retina, nerve fiber layer, lens densitometry.

Correlation of response to intravitreal bevacizumab treatment between the first and second treated eyes in diabetic macular edema

Purpose To evaluate whether outcome of bevacizumab treatment in the first treated eye can guide the selection of compound for the second treated eye in patients with bilateral diabetic macular edema. Methods Demographic, clinical, and optical coherence tomography data were retrospectively collected from consecutive patients who underwent bevacizumab therapy for bilateral diabetic macular edema. Change in central subfield thickness and visual acuity were evaluated and compared between the first treated eye and second treated eye. Results A total of 66 eyes of 33 patients were included in the study. The mean ± SD follow-up time was 13 ± 5 months. The mean ± SD central subfield thickness at baseline was 464 ± 30 μm in the first treated eye and 461 ± 29 μm in the second treated eye ( p = 0.91). Final central subfield thickness was reduced to 392 ± 27 μm in the first treated eye ( p = 0.01 compared with baseline) and 416 ± 25 μm in the second treated eye ( p = 0.03 compared with baseline). Using ≥5% or ≥10% reduction of central subfield thickness as diagnostic criteria to predict similar magnitude of thickness reduction in the first treated eye yielded a positive and negative predictive value ranging from 46% to 81%, and sensitivity and specificity ranging from 54% to 84%. Regression models did not show correlation between central subfield thickness reduction in first treated eye and the second treated eye at the end of follow-up. Conclusions Bevacizumab therapy reduced macular thickness in both eyes in bilateral diabetic macular edema. Treatment outcome of the first treated eye could not predict the outcome of the second treated eye. Particularly, failure to reduce central subfield thickness in the first treated eye does not preclude a favorable response to bevacizumab therapy in the second eye.

OCT-based biomarkers for predicting treatment response in eyes with centre-involved diabetic macular oedema treated with anti-VEGF injections: a real-life retina clinic-based study

Background/aimsTo determine whether a combination of baseline and change in spectral domain-optical coherence tomography (SD-OCT)-based biomarkers can predict visual outcomes in eyes with diabetic macular oedema (DMO) treated with antivascular endothelial growth factors (VEGF) injections.MethodsThis is a retrospective cohort study conducted in Hong Kong, China. 196 eyes with centre-involving DMO, who received anti-VEGF injections between 1 January 2011 and 30 June 2018 were recruited. Medical records of the participants were retrieved retrospectively, visual acuity (VA) at baseline, 6, 12 and 24 months and SD-OCT before initiation and after completion of anti-VEGF treatment were obtained. The SD-OCT images were evaluated for the morphology of DMO, vitreomacular status, presence of disorganisation of retinal inner layers (DRIL), sizes of intraretinal cysts, visibility of external limiting membrane (ELM), ellipsoid zone (EZ) and cone outer segment tip (COST) and the presence of hyper-reflective foci in retina or the choroid.ResultsThe presence of baseline DRIL, hyper-reflective foci in retina and disruption of ELM/EZ and COST were associated with worse baseline and subsequent VA up to 24 months after treatment. Improvement in DRIL (p=0.048), ELM/EZ (p=0.001) and COST (p=0.002) disruption after treatment was associated with greater improvement in VA at 12 months. Eyes with cystoid macular oedema (p=0.003, OR=8.18) and serous retinal detachment (p=0.011, OR=4.84) morphology were more likely to achieve at least 20% reduction in central subfield thickness.Conclusion and relevanceBaseline SD-OCT biomarkers and their subsequent change predict VA and improvement in vision in eyes with DMO treated with anti-VEGF injections. We proposed an SD-OCT-based system that can be readily used in real-life eye clinics to improve decision making in the management of DMO.

Infrared reflectance image-guided laser photocoagulation of telangiectatic capillaries in persistent diabetic macular edema

This study aimed to assess detection rate of telangiectatic capillaries (TelCaps) with infrared reflectance (IR) and optical coherence tomography (OCT) images and to evaluate the clinical efficacy of IR image-guided focal laser photocoagulation of TelCaps in persistent diabetic macular edema (DME). This retrospective case series included 28 eyes of 28 patients with TelCap and persistent DME refractory to intravitreal anti-vascular endothelial growth factor or corticosteroids. The presence of TelCaps was confirmed using IR and OCT images. All patients were followed up for more than 12 months after direct focal laser photocoagulation of the TelCaps. The TelCap closure rate, changes in best-corrected visual acuity, and central subfield thickness were analyzed. On IR imaging, TelCap appeared as a characteristic hyperreflectivity within a hyporeflective spherical lesion in 85.7% of the eyes. After focal laser photocoagulation, the TelCap closure rate was 57.1% at 3 months and 71.4% at 12 months. A significant improvement in visual acuity and reduction in central subfield thickness were observed at three and 12 months after focal laser photocoagulation (all p < 0.05). The characteristic hyperreflectivity within hyporeflective lesions on the IR image in conjunction with OCT helps identify the TelCap. Our results suggest that IR imaging and OCT-guided focal laser photocoagulation of TelCaps can improve functional and anatomical outcomes in persistent DME.

The 2-Year Leakage Index and Quantitative Microaneurysm Results of the RECOVERY Study: Quantitative Ultra-Widefield Findings in Proliferative Diabetic Retinopathy Treated with Intravitreal Aflibercept

Eyes with proliferative diabetic retinopathy (PDR) have been shown to improve in the leakage index and microaneurysm (MA) count after intravitreal aflibercept (IAI) treatment. The authors investigated these changes via automatic segmentation on ultra-widefield fluorescein angiography (UWFA). Forty subjects with PDR were randomized to receive either 2 mg IAI every 4 weeks (Arm 1) or every 12 weeks (Arm 2) through Year 1. After Year 1, Arm 1 switched to quarterly IAI and Arm 2 to monthly IAI through Year 2. By Year 2, the Arm 1 leakage index decreased by 43% from Baseline (p = 0.03) but increased by 59% from Year 1 (p = 0.04). Arm 2 decreased by 61% from Baseline (p = 0.008) and by 31% from Year 1 (p = 0.12). Both cohorts exhibited a significant decline in MAs from Baseline to Year 2 (871 to 410; p < 0.001; 776 to 207; p < 0.001, respectively). Subjects with an improved leakage and MA count showed a more significant improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Moreover, central subfield thickness (CST) was positively associated with changes in the leakage index. In conclusion, the leakage index and MA counts significantly improved from Baseline following IAI treatment, and monthly injections provided a more rapid and sustained reduction in these parameters compared with quarterly injections.

Das frühe Diabetische Makulaödem: Ein Indikator für schlechte postoperative Ergebnisse nach Katarakt Chirurgie bei Diabetikern. Die DICAT-II-Studie

<b>Background:</b> The prospective DIabetes and CATaract Study II (DICAT II) was performed to characterise the risks of cataract surgery to the retinae of patients with early diabetic macular oedema (E-DMO). <b>Methods:</b> DICAT II was a prospective, comparative, multicentre, observational study involving six Italian clinics. Patients were aged ≥55 years, had type 1 or 2 diabetes with spectral-domain optical coherence tomography evidence of ESASO classification Early DMO. Group 1 eyes (78 eyes, 78 patients) underwent phacoemulsification-based cataract surgery. Group 2 eyes (65 eyes, 65 patients) had E-DMO and either clear media or had undergone uncomplicated cataract surgery ≥1 year previously. Central subfield thickness (CST) and best-corrected visual acuity (BCVA) were assessed in both groups. <b>Results:</b> The negative impact of surgery on CST was evident after the first postoperative week; CST peaked during the first month, then rapidly decreased. CST worsening ≥10 µm was observed in 63/78 eyes (80.7%) and 29/65 eyes (44.6%) in Groups 1 and 2, respectively (<i>p</i> &#x3c; 0.0001). CST worsening of ≥50 µm was observed in 51 eyes (65.4%) and 10 eyes (15.4%) in Groups 1 and 2, respectively (<i>p</i> &#x3c; 0.0001). Mean CST worsening was lower in Group 2 than in Group 1 (38.6 ± 30.4 µm vs 85.5 ± 55.3 µm, <i>p</i> &#x3c; 0.0001) with a lower BCVA loss (−2.6 ± 3.5 letters vs −8.2 ± 6.2 letters, <i>p</i> &#x3c; 0.0001). Higher glycaemic levels and HBA1c levels were significantly associated with the risk of &#x3e;50 μm CST worsening in eyes from both groups. <b>Conclusion:</b> Early DMO is associated with poorer outcomes after cataract surgery and requires close pre- and postoperative monitoring.

Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).MethodsSetting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.