View clinical trials related to Optic Neuropathy, Ischemic.
Filter by:In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed. This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases. All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients. The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007). It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.
Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent but severe complication. Little is understood about this complication, but most cases seem to result from loss of blood flow to the optic nerve. This is a pilot, single center, prospective, randomized, two-arm study involving 20 subjects at The Ohio State University Wexner Medical Center who are scheduled to undergo spine surgery that requires prone position and at least two hours of general anesthesia or total intravenous anesthesia (TIVA) and intraoperative neurophysiological monitoring. Patients will be randomized to either general anesthesia or TIVA, and wear the SightSaver device to monitor visual evoked potentials (VEPs) during surgery in order to detect possible changes in optic nerve function that may lead to POVL. We hypothesize that this new, flexible, disposable device will yield better results and more patient satisfaction than devices currently used for visual monitoring during prone spine surgeries.
To follow all patients enrolled in the original Ischemic Optic Neuropathy Decompression Trial (IONDT) to determine (1) the incidence of non-arteritic ischemic optic neuropathy (NAION) in the second eye, (2) changes in visual acuity over time in both the study and second eye, and (3) other aspects of the natural history of NAION.