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To report the safety and efficacy of a novel cell-injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term clinical data of 5-years postoperative in a 'first-in-man' clinical trial group.
Prospective observational study.
This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC-injection therapy between December 2013 and December 2014.
All patients underwent follow-up examinations at 1-, 4-, 12-, and 24-weeks and 1-, 2-, 3-, 4-, and 5-years postoperative. Specific corneal endothelial cell parameters [i.e., corneal endothelial cell density (ECD), coefficient of variation of area, and percentage of hexagonal cells] and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure were recorded.
The primary outcome was the change of central ECD post cell-injection therapy, and the secondary outcome was corneal thickness, BCVA, and intraocular pressure during the 5-year-postoperative follow-up periods.
At 5-years postoperative, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean central corneal ECD was 1,257 ± 467 cells/mm
(± SD) (range, 601 to 2,067 cells/mm
), BCVA was significantly improved in 10 treated eyes, the mean logMAR VA had changed to 0.046 from that of 0.876 at prior to surgery, and no major adverse reactions directly related to the 'hCEC-injection therapy' were observed.
The findings in this study confirmed the safety and efficacy of cultured hCEC-injection therapy for up to 5-years postoperative.
The findings in this study confirmed the safety and efficacy of cultured hCEC-injection therapy for up to 5-years postoperative.
To determine whether the 10-2 test of the Humphrey Field Analyzer detected a higher proportion of abnormal visual fields compared with the 24-2 test in the central 10° of patients with early glaucomatous visual field damage.
Prospective observational study.
Patients with open-angle glaucoma and healthy control participants.
All participants underwent a 24-2 and 10-2 test. Only the 12 central test locations of the 24-2 test were included to analyze equivalent visual field areas. click here The performance of the 2 tests was compared across 4 pointwise criteria total deviation (TD) and pattern deviation (PD) analyses at the 5% and 2% levels. Analyses also were conducted for 2 pairs of follow-up tests, each performed 4 months apart.
(1) Area under the receiver operating characteristic curve (AUC), (2) sensitivity at identically matched specificity for the 4 criteria, (3) overlap (entire field and by quadrant) of abnormal visual fields with both tests, and (4) repeatability of the findings in 2 subsequent follow-ued patients with higher risk of central visual field progression.
In this study of glaucoma patients with early damage with the 24-2 test, there was little evidence that adding the 10-2 test revealed additional undetected defects in the central visual field. It may be more prudent to reserve 10-2 testing for following up selected patients with higher risk of central visual field progression.Elevated intraocular levels of angiogenic cytokines such as vascular endothelial growth factor (VEGF) have been implicated the development of diabetic retinopathy. Over a decade of clinical evidence shows intravitreal injection of anti-VEGF agents is associated with decreased disease progression and preservation of vision. However, the treatment burden associated with monthly injections limits the effectiveness of existing anti-VEGF therapies. Current research has focused on sustained treatment paradigms such as longer acting drugs, drug delivery implants, and gene therapy. In this study, we tested a novel approach by dialyzing proteins from the vitreous using bioceramic implant composed of hydroxyapatite. Preliminary in vitro and in vivo studies demonstrate a high affinity and capacity for VEGF absorption. After three months implantation in New Zealand White Cross rabbits, the hydroxyapatite demonstrated good biocompatibility with no inflammation and normal retinal physiology and histology. These studies demonstrate that prolonged VEGF suppression intraocularly may be accomplished with a bioceramic implant.We are reporting for the first time the synthesis and application of an innovative nanometric system for the controlled topic release of melatonin in the retina. The ethylcellulose nanocapsules were characterized by diverse physicochemical techniques (scanning electron microscopy, zeta potential, hydrodynamic diameters) and an in vitro release study was done. A complete ex vivo and in vivo trans-corneal permeation and an irritation study were carried out with the new formulations in albino rabbits, to which a retinal degenerative model was induced. The results obtained demonstrate that the in vitro release of melatonin (1 mg/mL and 2 mg/mL) transported by nanocapsules is slower when compared to a solution of melatonin. Greater penetration of melatonin through the cornea was demonstrated by ex vivo and in vivo tests. This can be attributable to an enhanced neuroprotective effect of melatonin on retinal ganglion cells when it is included in ethylcellulose nanocapsules compared to a solution of melatonin. These outstanding findings add promising new perspectives to current knowledge about administrations using nano-technological tools in the treatment of neurodegenerative diseases at the ocular level.The aim of this study was to elucidate the intracellular sources of oxidant species, the antioxidant response as well as the main signaling pathways involved in the regulation of the redox balance in the primary visual cortex of rats subjected to an experimental glaucoma model. 3-month female Wistar strain rats were operated under a microscope by cauterizing two of the episcleral veins in order to elevate the intraocular pressure (glaucoma group); the control group received a sham procedure. Seven days after surgery, the animals were sacrificed, the brains were carefully removed, and the primary visual cortex was dissected. NADPH oxidase (NOX) activity, as well as the inducible nitric oxide synthase (iNOS) expression, the enzymatic antioxidant defenses, the metabolism of glutathione, and the translocation of Nuclear factor-erythroid 2-related factor-2 (Nrf2) and Nuclear factor k-light-chain-enhancer of activated B cells (NF-κB) were assessed. Compared to control, glaucoma group displayed an increase in NOX activity (147%, p less then 0.