Active clinical trials for "Optic Nerve Injuries"

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Eye diseases

Purpose: Patients with severe traumatic optic neuropathy (TON) have limited improvement in visual function despite therapy. The hypothesis of the study is that the targeted shortwave diathermy combined with perceptual training may enhance visual function in patients with severe TON after endoscopic optic nerve decompression (EOND) surgery. Design: Clinical trial Subjects: Twenty-two subjects with severe TON after EOND surgery were randomly assigned to either a rehabilitation (Reh) group or nonrehabilitation (Nreh) group. Methods: High-resolution computed tomography and MRI were used to locate the impaired nerve. The subjects in the Reh group received targeted shortwave diathermy therapy 5 days per week for 4 weeks and perceptual training 5 days per week for 10 weeks. Main Outcome Measures: A thorough evaluation of visual function, visual evoked potential, and diffusion tensor imaging was executed.

The aim of the project is to create a new, non-invasive and safe protocol for the early diagnosis of various types of optic neuropathies with the use of diffusion magnetic resonance imaging

The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.

The pathophysiology of Traumatic Optic Neuropathy (TON) is thought to be multifactorial, and some researchers have also postulated a primary and secondary mechanism of injury.TON is categorized as direct or indirect.In indirect TON cases, the injury to the axons is thought to be induced by shearing forces that are transmitted to the fibers or to the vascular supply of the nerve. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. Such injury leads to ischemic injury to the axons of the retinal ganglion cells within the optic canal. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Generally no line precedes the others and additionally, medical or surgical interventions may result in serious side effects or complications. In 2005, the results of the Corticosteroid Randomization after Significant Head Injury (CRASH) trial raised concerns regarding the use of mega dose steroids in traumatic brain injury. This study was the largest randomized study that evaluated steroids in patients with traumatic brain injury and was stopped early due to the significantly increased risk of death in patients that received mega dose steroids at their 6-month follow-up when compared with the placebo group (25.7% vs 22.3%; Relative Risk 1.15 Confidence Interval 1.07 to 1.24; p=0.0001). Although the etiology of the increased risk of death was not determined, the findings of this study should be taken into consideration when managing cases of TON with concurrent traumatic brain injury. Very recently it has been shown the cytokine hormone erythropoietin (EPO) that had been long known and used as a valuable agent to promote hematopoiesis has been protective in experimental models of mechanical trauma, neuroinflammation, cerebral and retinal ischemia, and even in a human stroke trial, and most notably in optic nerve transection. A double blind placebo-controlled multicenter trial on EPO add-on treatment in chronic schizophrenic men was performed. Treatment over 12 weeks with high-dose weekly (40,000 IU intravenously) EPO led to significant improvement of cognitive performance compared to placebo controls. Different studies have been performed on the effect of EPO on neuropathy in different studies. The investigators recently published our results on treating patients with TON with EPO and found it safe and effective. Patients were compared with a historical control group of patients who received no treatment for TON. A better visual recovery was found. The aim of this study is to determine the effectiveness of EPO on TON in a Multi- center clinical trial using a semi-experimental design.

After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).

Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field (primary outcome measure).

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past. Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.

A randomized, double-blind, placebo-controlled, single/multiple dose study of recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, tolerability and pharmacokinetics