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Effectiveness of microperimetry in evaluating anti-vascular endothelial growth factor therapy for diabetic macular edema patients with relatively good vision: A retrospective observational study.
Sugimoto, M, Wakamatsu, Y, Miyata, R, Kato, K, Matsubara, H, Kondo, M
Medicine. 2021;(51):e28404
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Abstract
No studies have evaluated the retinal sensitivity (RS) for diabetic macular edema (DME) patients with good vision. Therefore, this study aimed to determine the effectiveness of microperimetry in evaluating the effectiveness of anti-vascular endothelial growth factor (anti-VEGF) treatment for DME patients with relatively good vision.Twenty-seven eyes of 27 patients (mean age, 61.3 ± 11.2 years) with DME and decimal best-corrected visual acuity (BCVA) ≥0.6 were studied. All patients received 3 consecutive monthly injections of intravitreal anti-VEGF agents. The BCVA, central subfield macular thickness (CMT), and RS were evaluated by microperimetry (MAIA) within the 10 degree of the foveal center. To determine significant differences between the values, we used paired t tests.Patients were evaluated at baseline and 4 weeks after the third injection. The BCVA improved significantly from 0.18 ± 0.06 logarithm of the minimum angle of resolution (logMAR) units to 0.13 ± 0.13 logMAR units (P = .002; paired t test). The CMT decreased significantly from 464.3 ± 91.8 μm to 393.4 ± 129.0 μm (P = .005), and the RS also improved significantly from 21.8 ± 3.1 dB to 24.1 ± 2.8 dB at 4 weeks after treatment (P = .006). Among the patients with a decimal BCVA of 0.7 or better at baseline, there was no significant improvement in the BCVA (P = .28). However, the CMT decreased significantly from 479.5 ± 79.1 μm to 394.0 ± 99.8 μm at 4 weeks after treatment (P = .007). The RS also improved significantly from 22.0 ± 2.4 dB to 24.0 ± 3.1 dB at 4 weeks after treatment (P = .004).Measuring RS by microperimetry is a good option for evaluating the effectiveness of anti-VEGF treatment for DME patients with a relatively good BCVA.
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Fluocinolone acetonide vitreous insert for chronic diabetic macular oedema: a systematic review with meta-analysis of real-world experience.
Fallico, M, Maugeri, A, Lotery, A, Longo, A, Bonfiglio, V, Russo, A, Avitabile, T, Furino, C, Cennamo, G, Barchitta, M, et al
Scientific reports. 2021;(1):4800
Abstract
We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing these findings with the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study. The primary outcome was mean change of best corrected visual acuity (BCVA) at 24 months. Secondary outcomes were 36-month mean BCVA, mean central macular thickness (CMT) change, rates of eyes receiving supplementary intravitreal therapy, cataract surgery, intraocular pressure (IOP)-lowering drops and glaucoma surgery. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Nine real-world studies were included. The FAc implant yielded a significantly improved BCVA at 24 and 36 months (24-month MD = 4.52; 95% CI 2.56-6.48; 36-month MD = 8.10; 95% CI 6.34-9.86). These findings were comparable with the FAME study. The FAc implant yielded significantly reduced 24- and 36-month CMT. Pooled proportions of cataract surgery, IOP-lowering drops and glaucoma surgery were 39%, 27% and 3%, respectively, all lower than the FAME study. Pooled estimate of supplementary intravitreal therapy was 39%, higher than the 15.2% of the FAME study. This meta-analysis of real-world studies confirms favorable visual and anatomical outcomes following FAc insert for chronic DMO. In real-life studies more than one third of patients received supplementary intravitreal therapy, an issue that needs to be further explored.
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Evaluation of a New Model of Care for People with Complications of Diabetic Retinopathy: The EMERALD Study.
Lois, N, Cook, JA, Wang, A, Aldington, S, Mistry, H, Maredza, M, McAuley, D, Aslam, T, Bailey, C, Chong, V, et al
Ophthalmology. 2021;(4):561-573
Abstract
PURPOSE The increasing diabetes prevalence and advent of new treatments for its major visual-threatening complications (diabetic macular edema [DME] and proliferative diabetic retinopathy [PDR]), which require frequent life-long follow-up, have increased hospital demands markedly. Subsequent delays in patient's evaluation and treatment are causing sight loss. Strategies to increase capacity are needed urgently. The retinopathy (EMERALD) study tested diagnostic accuracy, acceptability, and costs of a new health care pathway for people with previously treated DME or PDR. DESIGN Prospective, multicenter, case-referent, cross-sectional, diagnostic accuracy study undertaken in 13 hospitals in the United Kingdom. PARTICIPANTS Adults with type 1 or 2 diabetes previously successfully treated DME or PDR who, at the time of enrollment, had active or inactive disease. METHODS A new health care pathway entailing multimodal imaging (spectral-domain OCT for DME, and 7-field Early Treatment Diabetic Retinopathy Study [ETDRS] and ultra-widefield [UWF] fundus images for PDR) interpreted by trained nonmedical staff (ophthalmic graders) to detect reactivation of disease was compared with the current standard care (face-to-face examination by ophthalmologists). MAIN OUTCOME MEASURES Primary outcome: sensitivity of the new pathway. SECONDARY OUTCOMES specificity; agreement between pathways; costs; acceptability; proportions requiring subsequent ophthalmologist assessment, unable to undergo imaging, and with inadequate images or indeterminate findings. RESULTS The new pathway showed sensitivity of 97% (95% confidence interval [CI], 92%-99%) and specificity of 31% (95% CI, 23%-40%) to detect DME. For PDR, sensitivity and specificity using 7-field ETDRS images (85% [95% CI, 77%-91%] and 48% [95% CI, 41%-56%], respectively) or UWF images (83% [95% CI, 75%-89%] and 54% [95% CI, 46%-61%], respectively) were comparable. For detection of high-risk PDR, sensitivity and specificity were higher when using UWF images (87% [95% CI, 78%-93%] and 49% [95% CI, 42%-56%], respectively, for UWF versus 80% [95% CI, 69-88%] and 40% [95% CI, 34%-47%], respectively, for 7-field ETDRS images). Participants preferred ophthalmologists' assessments; in their absence, they preferred immediate feedback by graders, maintaining periodic ophthalmologist evaluations. When compared with the current standard of care, the new pathway could save £1390 per 100 DME visits and between £461 and £1189 per 100 PDR visits. CONCLUSIONS The new pathway has acceptable sensitivity and would release resources. Users' suggestions should guide implementation.
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Effectiveness and Safety of Coadministration of Intravitreal Dexamethasone Implant and Silicone Oil Endotamponade for Proliferative Diabetic Retinopathy with Tractional Diabetic Macular Edema.
Altun, A, Kanar, HS, Aki, SF, Arsan, A, Hacisalihoglu, A
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics. 2021;(2):131-137
Abstract
Purpose: To investigate the efficacy and safety of coadministered intravitreal dexamethasone (IVD) implant and silicone oil endotamponade during pars plana vitrectomy (PPV) for the treatment of proliferative diabetic retinopathy (PDR) with tractional diabetic macular edema (DME). Methods: In this prospective, controlled, and randomized clinical study, the eyes with PDR and vitreomacular traction syndrome that underwent PPV with silicone oil endotamponade were divided into 2 groups. Group 1 was defined as the control group, and no other procedures were performed. IVD was implanted to the eyes in Group 2. In both groups, panretinal photocoagulation was completed to the missed areas during PPV. All cases followed for 6 months, postoperatively. Retinal findings were followed with optical coherence tomography and fluorescein fundus angiography. Results: A total of 52 eyes of 52 patients were included in the study. Twenty-six eyes of 23 patients were included in both groups. The improvement in best corrected visual acuity was statistically significantly higher in Group 2 (P > 0.05). In the postoperative period, the DME development rate and intravitreal ranibizumab (IVR) injection requirement were significantly higher in Group 1 (P > 0.05). There was no statistically significant difference in the proliferative vitroretinopathy development rate between the groups (P < 0.05). Conclusion: Coadministration of IVD implant and silicone oil endotamponade to the eyes with PDR during vitrectomy seems to be safe and effective application and may decrease the rate of DME and the requirement of IVR injection.
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Add-on effect of Qiming granule, a Chinese patent medicine, in treating diabetic macular edema: A systematic review and meta-analysis.
Hu, Z, Xie, C, Yang, M, Fu, X, Gao, H, Liu, Y, Xie, H
Phytotherapy research : PTR. 2021;(2):587-602
Abstract
This study aims to evaluate the efficacy and safety of Qiming granule (QG) on diabetic macular edema (DME). PubMed, Embase, the Cochrane Library, CNKI, Wanfang, qvip and China Biology Medicine Disc were searched. Randomized controlled trials (RCTs) about participants with a diagnosis of DME were included. Risk of bias assessment was conducted by Cochrane risk-of-bias tool for RCT. Random-effects model was implemented to pool results. Among 16 included studies, QG combined with conventional treatment was administered 13.5 g daily for a period ranging from 2 to 6 months. Results showed combination therapy was more effective than conventional treatment alone in central macular thickness (weighted mean difference (WMD) = -29.43, 95% confidence interval (CI) (-39.56 to -19.29), p = .0001), optimum corrected vision (pooled standardized mean difference (SMD) = -0.962, 95%CI (-1.35 to -0.57), p = .0001) and overall effective rate (RR = 1.25, 95%CI = [1.13 to 1.35], p < .0001). Only three studies reported adverse effects. The quality of evidence is low. Due to a lack of placebo control, the net efficacy of QG is still uncertain. More high-quality RCTs are needed to confirm the efficacy and safety of QG in DME.
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Intravitreal bevacizumab versus intravitreal triamcinolone for diabetic macular edema-Systematic review, meta-analysis and meta-regression.
Abdel-Maboud, M, Menshawy, E, Bahbah, EI, Outani, O, Menshawy, A
PloS one. 2021;(1):e0245010
Abstract
BACKGROUND The most frequent cause of vision loss from diabetic retinopathy is diabetic macular edema (DME). Earlier clinical trials tried to examine the role of intravitreal triamcinolone (IVT) and intravitreal bevacizumab (IVB) in DME; they either qualified IVT over IVB or IVB over IVT or did not exhibit a significant difference. OBJECTIVE This paper aims to compare the efficacy and safety of IVB versus IVT alone or combined IVB+IVT in the treatment of DME. METHODS We systematically searched PubMed, CENTRAL, Scopus, Embase, Science Direct, OVID, and Web of Science for randomized controlled trials of IVB versus IVT alone or combined IVB+IVT and IVT versus the combined IVB+IVT in DME patients. RESULTS A total of 1243 eyes of 17 trials were included in our meta-analysis and regression. Repeated injections of IVB were superior at improving VA comparing with those of IVT at 12, 24, 48-weeks, and IVB+IVT at 12, 24, 48-weeks. Single injections were comparable across the three arms regarding BCVA improvement. CMT reductions were also comparable across the three arms. Meanwhile, the overall safety regarding intraocular pressure and intraocular hypertension significantly favored the IVB group. Improvement in VA was best modified with CMT reduction from 480 um to 320um. This association was significant at 12-weeks in the three arms and persisted till 24-weeks and 48-weeks exclusively in the IVB group. CONCLUSIONS AND RELEVANCE Our analysis reveals that repeated successive injections associate with better BCVA compared to single injection. Current evidence affirms that IVB is superior to IVT and IVB+IVT at improving BCVA, comparable at reducing CMT, and presents a better safety profile in the treatment of DME.
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Attendance Rate in Patients with Diabetic Macular Edema Receiving Short Messages.
Kumar, G, Velu, S, Prakash, VJ, Kumar, S, Sivaprasad, S, Sharma, A, Raman, R
Ophthalmology. Retina. 2021;(10):1054-1056
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Acute and subacute macular and peripapillary angiographic changes in choroidal and retinal blood flow post-intravitreal injections.
Arumuganathan, N, Wiest, MRJ, Toro, MD, Hamann, T, Fasler, K, Zweifel, SA
Scientific reports. 2021;(1):19381
Abstract
Whether post injectional acute intraocular pressure (IOP) increase is associated with decreased peripapillary and macular perfusion is still under debate. Here, we investigated early changes in the choroidal and retinal blood flow using OCTA imaging in a cohort of patients undergoing anti-VEGF intravitreal injections (IVI) for macular edema following retinal vein occlusion and diabetic retinopathy. In this prospective single-center, observational study, the pre- and post-IVI changes in retinal perfusion were examined via assessment of vessel length density (VLD) and vessel density (VD) in deep and superficial capillary segmentations (DCP and SCP), foveal avascular zone (FAZ) in SCP, as well as flow signal deficits in the choriocapillaris segmentation. Mean IOP significantly changed over the study course (p = 0.000; ANOVA). Measurements at 5 min post-IVI (33.48 ± 10.84 mmHg) differed significantly from baseline (17.26 ± 2.41 mmHg, p = 0.000), while measurements from one day, one week, and one-month post-IVI did not (p = 0.907, p = 1.000 and p = 1.000 respectively). In comparison to baseline, no changes in OCTA parameters, including FAZ, VD, VLD, and FV, were detected 5 min post-IVI. No significant alterations in OCTA parameters were observed during study course. Increased IOP spikes were detected post-IVI; however, no potential permanent ischemic retinal damage was suspected.
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Optical Coherence Tomography (Angiography) Biomarkers in the Assessment and Monitoring of Diabetic Macular Edema.
Suciu, CI, Suciu, VI, Nicoara, SD
Journal of diabetes research. 2020;:6655021
Abstract
Retinopathy is one of the most severe diabetes-related complications, and macular edema is the major cause of central vision loss in patients with diabetes mellitus. Significant progress has been made in recent years in optical coherence tomography and angiography technology. At the same time, various parameters have been attributed the role of biomarkers creating the frame for new monitoring and treatment strategies and offering new insights into the pathogenesis of diabetic retinopathy and diabetic macular edema. In this review, we gathered the results of studies that investigated various specific OCT (angiography) parameters in diabetic macular edema, such as central subfoveal thickness (CST), cube average thickness (CAT), cube volume (CV), choroidal thickness (CT), retinal nerve fiber layer (RNFL), retinal thickness at the fovea (RTF), subfoveal choroidal thickness (SFCT), central macular thickness (CMT), choroidal vascularity index (CVI), total macular volume (TMV), central choroid thickness (CCT), photoreceptor outer segment (PROS), perfused capillary density (PCD), foveal avascular zone (FAZ), subfoveal neuroretinal detachment (SND), hyperreflective foci (HF), disorganization of the inner retinal layers (DRIL), ellipsoid zone (EZ), inner segment/outer segment (IS/OS) junctions, vascular density (VD), deep capillary plexus (DCP), and superficial capillary plexus (SCP), in order to provide a synthesis of biomarkers that are currently used for the early diagnosis, assessment, monitoring, and outlining of prognosis.
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Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial.
Fazel, F, Nikpour, H, Pourazizi, M
BioMed research international. 2020;:6794391
Abstract
PURPOSE To evaluate the efficacy of three intravitreal bevacizumab (IVB) injections versus the same combined with 2% of topical dorzolamide in the treatment of diabetic macular edema (DME). METHODS In this randomized double-masked clinical trial, 32 eyes of 16 treatment-naive patients with bilateral DME were enrolled. The eyes were randomly assigned to receive three monthly injections of IVB (1.25 mg) plus topical dorzolamide 2% twice daily or IVB (1.25 mg) plus topical artificial tear twice daily. Best-corrected visual acuity (BCVA) was the primary outcome of the study followed by the central macular thickness (CMT) and central macular volume (CMV) as the secondary outcomes. RESULTS Mean BCVA changes were insignificant in both groups. It changed from 0.21 ± 0.08 logMAR at baseline to 0.23 ± 0.09 (P=0.24) in the combination group and from 0.18 ± 0.09 logMAR to 0.21 ± 0.09 (P=0.11) in the IVB alone group, at 3 months, respectively. Changes in mean CMT and CMV were significant in both groups. However, the difference between the groups was not significant at all the visits. In the study, no major ocular complication or systemic side effects were noted regarding IVB or topical dorzolamide. CONCLUSION This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course. This trial is registered with the Iranian Registry of Clinical Trials under the registration code IRCT20131229015975N5.