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This study compared the efficacy safety profiles of the Xen 63 and Preserflo MicroShunt devices, both standalone, in patients with primary open-angle glaucoma (POAG). It is a retrospective and single-center study conducted on consecutive on patients with medically uncontrolled POAG who underwent either a standalone Xen 63 or a standalone Preserflo and had a 12-month follow-up visit. The primary outcome was the mean IOP at month-12. Sixty eyes were included, 30 eyes in each Xen 63 and Preserflo groups, respectively. Preoperative IOP was significantly lowered from 20.8 ± 3.6 mmHg and 19.1 ± 3.8 mmHg to 14.2 ± 4.5 mmHg and 12.8 ± 2.3 mmHg in the Xen 63 and Preserflo groups, respectively ( p  < 0.0001 each, respectively); without significant differences between groups ( p  = 0.1346). Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.6 to 0.2 ± 06 drugs and from 2.3 ± 0.7 to 0.3 ± 0.6 drugs, in the Xen 63 and Preserflo groups, respectively ( p  < 0.0001 each, respectively); without significant differences between groups ( p  = 0.5212). Regarding safety, one (3.3%) eye in the Preserflo group required a device removal due to maculopathy. Three (10.0%) eyes in the Xen 63 group underwent needling. In conclusion, both the Xen 63 and the Preserflo devices effectively and safely reduced IOP and the requirement for IOP-lowering medications, exhibiting comparable IOP levels after 12 months.

To assess the effectiveness and safety of the Preserflo Microshunt (PMS) implantation combined with cataract surgery in open-angle glaucoma (OAG) patients. Retrospective, open-label study conducted on insufficiently controlled OAG patients, who underwent a PMS implant procedure with mitomycin-C 0.2%, either alone or in combination with cataract surgery, and were followed for at least 12 months. Success was defined as an intraocular pressure (IOP) ≤ 18 mmHg and a reduction of at least 20% without (complete) or with (qualified) hypotensive medication. Fifty-eight eyes were included in the study, 35 eyes underwent PMS alone and 23 underwent PMS + Phaco. In the overall study sample, mean IOP was significantly lowered from 21.5 ± 3.3 mmHg at baseline to 14.6 ± 3.5 mmHg at month 12 (p < 0.0001). The IOP was significantly reduced in both groups; p < 0.0001 each, respectively. Ocular hypotensive medication was significantly reduced (p < 0.0001) in both groups. No significant differences were observed in IOP lowering or medication reduction between groups. At month 12, 62.1% eyes were considered as complete success and 82.8% eyes as qualified success. The most common adverse events were device close-to-endothelium, conjunctival fibrosis, and wound leakage. PMS, either alone or in combination with phacoemulsification, may be considered as a valuable option for treating OAG patients.

ObjectiveTo evaluate the differences in peripapillary and macular vascular parameters by optical coherence tomography angiography (OCTA) between patients with primary congenital glaucoma (PCG) and healthy controls; and to determine their diagnostic accuracy.Material and methodsObservational, cross-sectional study including 39 eyes with PCG and 78 healthy eyes. Only one eye per patient was included. All included patients underwent a comprehensive ophthalmic examination and peripapillary and macular analysis were performed by AngioplexTM OCTA (Cirrus HD-OCT 5000) with a 4.5 × 4.5 mm optic nerve head scan and 6 × 6 mm macular scan. Global data and quadrant data from peripapillary vascular parameters and global data and circular sectors data from macular superficial plexus parameters were compared between groups. The glaucoma discrimination capability of these parameters was calculated as areas under the receiver operating characteristics curve (AUC ROC).ResultsMean age was 14.1 ± 8.7 years for the PCG patients and 11.7 ± 6.2 years for controls (p = 0.093). All vascular peripapillary measurements (global and quadrants; all p < 0.001) and all macular measurements (p < 0.042) excepting perfusion density in the inner circle (p = 0.087), were reduced in the PCG group compared to controls. According to AUC ROC, peripapillary (all ≥ 0.706) and macular parameters (all ≥ 0.699) showed good diagnostic capacity. AUC ROC for the most discriminatory measurements corresponding to blood flux index (0.887) and whole macula vascular density (0.855) were similar (p = 0.085).ConclusionPeripapillary and macular vascular parameters by OCTA are decreased in patients with PCG, showing a good capacity to discriminate between normal and glaucomatous eyes.

PurposeTo compare the diagnostic performance of circumpapillary retinal nerve fiber layer (cpRNFL) analysis versus segmented ganglion cell complex analysis both by spectral-domain optical coherence tomography (SD-OCT) in children with primary congenital glaucoma (PCG).MethodsParticipants were 40 children diagnosed with PCG and 60 healthy children. Ophthalmological data collected (for one eye per child) were cup-disc ratio (C/D) and axial length (AL). SD-OCT with automated segmentation was used to measure the thicknesses and volumes of the macular retinal nerve fiber layer (mRNFL), ganglion cell layer (GCL), and inner plexiform layer (IPL). For the cpRNFL measurements conventional S-D OCT software was used and the capacity of each method to discriminate between normal and glaucomatous eyes was compared.ResultsMean age was 11.20 ± 3.94 years for the glaucoma patients and 10.90 ± 2.46 years for controls (p = 0.64). All measurements were reduced (thinner) in the glaucoma group, significantly so for: cpRNFL, GCL, IPL and outer-superior and outer-inferior quadrant mRNFL. According to their areas under the receiver operating characteristics curve (AUC), temporal superior cpRNFL (0.869) and outer superior GCL (0.840), IPL (0.799), and mRNFL (0.767) showed the better diagnostic capacity. No differences were observed in AUCs for the most discriminatory cpRNFL and macular measurements.ConclusionSegmented macular layer analysis shows a good capacity to discriminate between normal and glaucomatous eyes; which is comparable to that of cpRNFL analysis in children with PCG.

Objective  To compare intraocular pressure (IOP) measurements obtained using the new transpalpebral Easyton® tonometer and Perkins applanation tonometer (PAT) in three different clinical populations. Methods The participants of this prospective study were 84 subjects divided into the groups: 22 healthy children (G1), 42 healthy adults (G2), and 20 adult patients with primary open angle glaucoma (G3). The data recorded in 84 eyes of these subjects were age, sex, gender, central corneal thickness (CCT), and axial length (AL). In all eyes, IOP was determined in the same examination room by the same experienced examiner using Easyton® and PAT in random order. Results  Mean differences in IOP readings between Easyton® and PAT were 0.45 ± 1.97 ( p  = 0.295), − 0.15 ± 2.13 ( p  = 0.654), − 1.65 ± 3.22 ( p  = 0.033), and − 0.018 ± 2.50 mmHg ( p  = 0.500) in the groups G1, G2, G3, and whole sample (G4), respectively. Correlations between Easyton® and PAT IOP values were 0.668 ( p  = 0.001) for G1, 0.463 ( p  = 0.002) for G2, 0.680 ( p  < 0.001) for G3, and 0.605 ( p  < 0.001) for G4. Moderate to good agreement between the two tonometers was found in all groups according to intraclass correlation coefficients, which were 0.794 ( p  < 0.001) for G1, 0.632 ( p  < 0.001) for G2, 0.809 ( p  < 0.001) for G3, and 0.740 ( p  < 0.001) for G4. The lower and upper limits of agreement between the devices were − 5.1 and 4.7 mmHg, respectively, in the complete group. No correlation was noted between CCT or AL and the Easyton® IOP measurements. Conclusion IOP measurements obtained with Easyton® and PAT show an acceptable level of agreement mainly in healthy individuals, recommending it for IOP screening in children and in patients in which PAT measurement may be impared as patients with hemifacial spasms, corneal irregularities, or reduced mobility. It is not recommended for glaucoma patients follow-up.

Progestin is a term used to describe a synthetic progestogen. The activity and potency of synthetic progestins are mostly evaluated via parameters associated with their endometrial effects, which are related to their interactions with progesterone, estrogen, androgen, glucocorticoid, and mineralocorticoid receptors. The chemical structure of progestins is the key to understanding their interactions with these receptors and predicting the other effects associated with these drugs. Due to their endometrial effect, progestins are used for different gynecological conditions, such as endometriosis, contraception, hormonal replacement therapy, and artificial reproduction techniques. This review is focused on improving our knowledge of progestins (from their history and biochemical effects related to their chemical structures to clinical applications in gynecological conditions) in order to improve clinical practice.

We aimed to assess the clinical validity of circulating tumour cell (CTC) quantification for prognostication of patients with metastatic breast cancer by undertaking a pooled analysis of individual patient data. We contacted 51 European centres and asked them to provide reported and unreported anonymised data for individual patients with metastatic breast cancer who participated in studies between January, 2003, and July, 2012. Eligible studies had participants starting a new line of therapy, data for progression-free survival or overall survival, or both, and CTC quantification by the CellSearch method at baseline (before start of new treatment). We used Cox regression models, stratified by study, to establish the association between CTC count and progression-free survival and overall survival. We used the landmark method to assess the prognostic value of CTC and serum marker changes during treatment. We assessed the added value of CTCs or serum markers to prognostic clinicopathological models in a resampling procedure using likelihood ratio (LR) χ2 statistics. 17 centres provided data for 1944 eligible patients from 20 studies. 911 patients (46·9%) had a CTC count of 5 per 7·5 mL or higher at baseline, which was associated with decreased progression-free survival (hazard ratio [HR] 1·92, 95% CI 1·73–2·14, p<0·0001) and overall survival (HR 2·78, 95% CI 2·42–3·19, p<0·0001) compared with patients with a CTC count of less than 5 per 7·5 mL at baseline. Increased CTC counts 3–5 weeks after start of treatment, adjusted for CTC count at baseline, were associated with shortened progression-free survival (HR 1·85, 95% CI 1·48–2·32, p<0·0001) and overall survival (HR 2·26, 95% CI 1·68–3·03) as were increased CTC counts after 6–8 weeks (progression-free survival HR 2·20, 95% CI 1·66–2·90, p<0·0001; overall survival HR 2·91, 95% CI 2·01–4·23, p<0·0001). Survival prediction was significantly improved by addition of baseline CTC count to the clinicopathological models (progression-free survival LR 38·4, 95% CI 21·9–60·3, p<0·0001; overall survival LR 64·9, 95% CI 41·3–93·4, p<0·0001). This model was further improved by addition of CTC change at 3–5 weeks (progression-free survival LR 8·2, 95% CI 0·78–20·4, p=0·004; overall survival LR 11·5, 95% CI 2·6–25·1, p=0·0007) and at 6–8 weeks (progression-free survival LR 15·3, 95% CI 5·2–28·3; overall survival LR 14·6, 95% CI 4·0–30·6; both p<0·0001). Carcinoembryonic antigen and cancer antigen 15-3 concentrations at baseline and during therapy did not add significant information to the best baseline model. These data confirm the independent prognostic effect of CTC count on progression-free survival and overall survival. CTC count also improves the prognostication of metastatic breast cancer when added to full clinicopathological predictive models, whereas serum tumour markers do not. Janssen Diagnostics, the Nuovo-Soldati foundation for cancer research.