AimsThe ILUVIEN Registry Safety Study is an ongoing, multicentre, open-label, observational study collecting real-world data on the safety and effectiveness of the 0.2 µg/day fluocinolone acetonide (FAc) implant in patients treated according to the European label requirements.MethodsPatients included in this analysis were treated for the licensed indication of chronic diabetic macular oedema (cDMO; that is, DMO that persists or recurs despite treatment). Data presented in the current analysis were collected from patient records up to 6 March 2017. Visual acuity (VA) data, including mean change in VA over time and at last observation, intraocular pressure (IOP) over the course of the study, IOP events, use of IOP-lowering therapy and cup:disc ratio were analysed. Information on additional DMO treatments post-FAc implant was also captured.ResultsFive hundred and sixty-three patients (593 eyes) were enrolled on the study. Mean IOP for the overall population remained within the normal range throughout follow-up and 76.7% of patients did not require IOP-lowering therapy following treatment with the FAc implant. Sixty-nine per cent of eyes did not require additional DMO treatments. Mean VA in the overall population increased from 51.9 letters at baseline to 55.6 letters at month 12, with a significant increase of 2.9 letters at last observation. Patients with short-term cDMO experienced greater VA gains than those with long-term cDMO.ConclusionsThe results of this analysis are comparable with those of other studies, including the Fluocinolone Acetate for Macular Edema study. The study reinforces the good safety and effectiveness profile of FAc, and demonstrates the benefit of early FAc treatment.
Purpose To evaluate the treatment of central serous chorioretinopathy (CSC) with either subthreshold diode laser MicroPulse (SDM) or intravitreal bevacizumab (BCZ). Methods This comparative, controlled, prospective study conducted over a period of 10 months examined 52 eyes of 52 patients with (a) treatment with SDM at the active leakage site guided by fluorescein angiography (FA) (n ¼ 16 eyes), (b) intravitreal injection of 1.25 mg BCZ (n ¼ 10 eyes), or (c) observation (n ¼ 26 eyes). Outcome measures included changes in retinal pigment epithelium (RPE) leakage at FA, central macular thickness (CMT), best-corrected visual acuity (BCVA), and 101 macular perimetry. Results At the end of the study, there was 12.5% persistent leakage in the SDM, compared with 60% in the BCZ and 92% in the control group. Mean CMT decreased by 94 lm in the SDM, 38 lm in the BCZ, and did not change in the control group. Mean BCVA improved more than 6 early treatment of diabetic retinopathy study letters in the SDM, decreased by one letter in the BCZ, and by two letters in the control group. In the SDM group, mean perimetric deficit improved by 1.5 decibels and corrected lost variance by 2.6. In the BCZ, it improved by 0.6, and in the control group by 0.5. Retreatment was required in 7/16 eyes of the SDM group (43.75%), and in 5/10 eyes of the BCZ group (50%). Conclusion SDM photocoagulation was superior to intravitreal injections of 1.25 mg BCZ in the treatment of CSC, which resulted in enhanced visual acuity and macular perimetry.
ABSTRACT.Purpose: To compare cytokines in undiluted vitreous of treatment-naı¨ve patients with macular oedema without vitreomacular traction secondary to branch (BRVO), central (CRVO) and hemi-central (H-CRVO) retinal vein occlusion. Methods: Ninety-four patients (median age 72 years, 42 men) underwent an intravitreal combination therapy, including a single-site 23-gauge core vitrectomy and the application of bevacizumab and dexamethasone due to vision-decreasing macular oedema. Among these were 43 patients with BRVO, 35 with CRVO and 16 patients with hemi-CRVO, which were distributed in a fresh or old retinal vein occlusion type (seven or more months after onset). Undiluted vitreous samples were analysed for interleukin 6 (IL-6), monocyte chemoattractant protein-1 (MCP-1) and vascular endothelial growth factor (VEGF-A) with cytometric BEAD assay. Vitreous samples from patients with idiopathic epiretinal membrane served as controls (n = 14). Results: The mean cytokine values were highest in the CRVO group with IL-6 = 64.7 pg ⁄ ml (SD ± 115.8), MCP-1 = 1015.8 pg ⁄ ml (±970.1) and VEGF-A = 278.4 pg ⁄ ml (±512.8), followed by the H-CRVO group with IL-6 = 59.9 pg ⁄ ml (SD ± 97.5), MCP-1 = 938.8 pg ⁄ ml (±561.1) and VEGF-A = 211.5 pg ⁄ ml (±232.4). The BRVO group had IL-6 = 23.2 pg ⁄ ml (SD ± 48.8), MCP-1 = 602.6 pg ⁄ ml (±490.3) and VEGF-A = 161.8 pg ⁄ ml (±314.4). The values of MCP-1 and VEGF-A were significantly different for CRVO or H-CRVO versus BRVO. All values were significantly higher than in the control samples, which had 6.2 ± 3.4 pg ⁄ ml (IL-6), 253 ± 74 pg ⁄ ml (MCP-1) and 7 ± 4.9 pg ⁄ ml (VEGF-A). Within the old RVO type, only MCP-1 was significantly different for CRVO or H-CRVO versus BRVO. Conclusions: Both inflammatory markers and VEGF-A were higher in CRVO and H-CRVO than in BRVO undiluted vitreous samples. It seems that monocyte recruitment to the vessel wall, which might underlie the importance of eosinophils in tissue remodelling after RVO, is of special interest owing to the significant difference in MCP-1 in the older RVO types.Key words: cytometric bead array -interleukin 6 -monocyte chemoattractant protein -retinal vein occlusion -vascular endothelial growth factor -vitreous samples Acta Ophthalmol. 2012: 90: e98-e103
PurposeTo evaluate the efficacy of the virtual reality training simulator Eyesi to prepare surgeons for performing pars plana vitrectomies and its potential to predict the surgeons’ performance.MethodsIn a preparation phase, four participating vitreoretinal surgeons performed repeated simulator training with predefined tasks. If a surgeon was assigned to perform a vitrectomy for the management of complex retinal detachment after a surgical break of at least 60 hours it was randomly decided whether a warmup training on the simulator was required (n = 9) or not (n = 12). Performance at the simulator was measured using the built-in scoring metrics. The surgical performance was determined by two blinded observers who analyzed the video-recorded interventions. One of them repeated the analysis to check for intra-observer consistency. The surgical performance of the interventions with and without simulator training was compared. In addition, for the surgeries with simulator training, the simulator performance was compared to the performance in the operating room.ResultsComparing each surgeon’s performance with and without warmup trainingshowed a significant effect of warmup training onto the final outcome in the operating room. For the surgeries that were preceeded by the warmup procedure, the performance at the simulator was compared with the operating room performance. We found that there is a significant relation. The governing factor of low scores in the simulator were iatrogenic retinal holes, bleedings and lens damage. Surgeons who caused minor damage in the simulation also performed well in the operating room.ConclusionsDespite the large variation of conditions, the effect of a warmup training as well as a relation between the performance at the simulator and in the operating room was found with statistical significance. Simulator training is able to serve as a warmup to increase the average performance.
Resistance to activated protein C (APC) is among the coagulation disorders that have been implicated in retinal vein occlusion. However, since retinal vascular occlusions may be due to a combination of several mechanisms, the question of whether thrombophilic anomalies are pathogenic for this disorder remains controversial. In the current study, we investigated the prevalence of APC resistance in patients with retinal vein occlusion with reference to age and various cardiovascular risk factors. A cohort of 142 consecutive patients with retinal vein occlusion and a control group of 128 subjects matched for age, sex and several risk factors were screened for resistance to APC. Both cohorts were divided into two subgroups, according to the patient's age (< or =45 or >45 years) at the time of the retinal vein occlusion or a previous thromboembolic event. The proportion of individuals with resistance to APC was higher in the patient group (13 of 142; 9.1%) when compared to controls (6 of 128; 4.7%). Moreover, patient age < or =45 years by the time of the retinal vein occlusion or a previous thromboembolic event was significantly associated with a high prevalence of APC resistance (17%). By contrast, resistance to APC was present in 5 of 95 cases (5.3%) in the patient group >45 years and in 4 of 83 (4.8%) young controls. Our results indicate that APC resistance is highly prevalent in patients with retinal vein occlusion at age < or =45 years and/or with a history of thrombosis at this age. By contrast, the prevalence of APC resistance in patients who suffered a retinal vein occlusion when they were older than 45 years and had no history of thromboembolism appears to be similar to that seen in healthy control subjects or in the normal population. Selective screening may be helpful in identifying retinal vein occlusion patients with thrombophilic defects.
In comparison to the control group, hdPDT and SDM resulted in reduced leakage activity in FA and enhanced photopic and scotopic visual acuity in patients with CSC.
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