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Optic Nerve Diseases clinical trials

View clinical trials related to Optic Nerve Diseases.

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NCT ID: NCT01975324 Completed - Clinical trials for Non Arteritic Ischemic Optic Neuropathy

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Ampyra
Start date: July 2013
Phase: Phase 4
Study type: Interventional

Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

NCT ID: NCT01892943 Completed - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Start date: August 2013
Phase: N/A
Study type: Observational

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON). Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed. The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey. Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

NCT ID: NCT01862627 Completed - Clinical trials for Normal Tension Glaucoma

Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy

Start date: December 2004
Phase: N/A
Study type: Observational

Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.

NCT ID: NCT01783847 Completed - Clinical trials for Traumatic Optic Neuropathy

Traumatic Optic Neuropathy Treatment Trial (TONTT)

TONTT
Start date: February 2015
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT01673815 Completed - Clinical trials for Other Disorders of Optic Disc, Bilateral

Video Diversion During Fundoscopic Exam in Children

CAFE
Start date: August 2011
Phase: N/A
Study type: Interventional

Fundoscopy is an important aspect of the neurological examination, but can be challenging in uncooperative children. This study explored whether viewing a video (selected by patient or caregiver) during eye examination improves the success, duration and ease of pediatric fundoscopy. Hypothesis: Showing a short video clip during a fundoscopic exam will increase the probability of successfully visualizing the optic disk and reduce the amount of time needed to perform a fundoscopic exam in children between 1-8 years old.

NCT ID: NCT01614158 Completed - Clinical trials for Non-arteritic Ischemic Optic Neuropathy

Assessment of Visual Field-related Endpoints in Patients With Non-arteritic Ischemic Optic Neuropathy

Pilot-SINN
Start date: April 2009
Phase: N/A
Study type: Observational

This present research project intends to collect five quantitative test series: - perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time - D-BCVA, using FrACT [Bach 2007] and EDTRS chart [Ferris 1982] - RAPD (using swinging flashlight test). - IOP (using applanation tonometer) - RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm, and volume scan) Optic disk morphology will be documented by fundus photography. This assessment of the above-mentioned data is needed in order to allow for estimation of the spontaneous course / fluctuation of the (quantified) functional and morphometric parameters of the N-AION patients during the follow-up period. This is essential for the estimation of the sample size of the subsequently intended SINN study, that is intended to compare different therapeutic strategies in N-AION patients.

NCT ID: NCT01421381 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy

RHODOS Follow-up Single-visit Study

RHODOS-OFU
Start date: September 2011
Phase: N/A
Study type: Observational

This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.

NCT ID: NCT01411657 Completed - Clinical trials for Ischemic Optic Neuropathy/Optic Nerve Stroke

NT-501 CNTF Implant for Ischemic Optic Neuropathy: Safety, Neuroprotection and Neuroenhancement

Start date: April 2011
Phase: Phase 1
Study type: Interventional

Ciliary Neurotrophic Factor (CNTF) has been demonstrated in multiple preclinical models to enhance survival and regeneration of retinal ganglion cells, the retinal neurons injured in diseases like ischemic optic neuropathy/optic nerve stroke. We hypothesize that CNTF delivery to the human eye will provide neuroprotection (prevent loss of vision) and neuroenhancement (improve vision indices) in ischemic optic neuropathy. Patients in the trial will receive an NT-501 CNTF implant (made by Neurotech) into one eye, and will be carefully followed to evaluate safety and efficacy.

NCT ID: NCT01404247 Completed - Retinal Diseases Clinical Trials

Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates

OCT
Start date: January 2011
Phase: Phase 1
Study type: Interventional

Brief Summary The purpose of this study is to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). This new technology provides a very detailed cross-section picture of the cellular layers in the retina and a 3-dimensional picture of the optic nerve head and the fovea (the center of the retina that provides the most accurate vision). These images have been used by doctors for more than 5 years to help diagnose and treat adults with eye diseases, such as macular degeneration, diabetic retinopathy, retinal detachments, and melanoma. But, it has never been studied in newborns. In newborns, it would potentially help in the diagnoses of glaucoma, optic nerve hypoplasia, foveal hypoplasia, and colobomata among many other disorders. Prior to diagnosing disorders, it is necessary to establish normal values. It is the purpose of this investigation to study the retina and optic nerves in neonates to establish normal values. After a parent of a normal newborn provides a written consent, the baby will be taken to the Eye Clinic where the instrument is located. The baby will be swaddled in one or more blankets as needed. The infants will be held in front of the instrument by a nurse. The technician will move the lens of the instrument to about 2 to 4 inches from the baby's eye. The mild light from the instrument will then enter the eye for a few seconds to obtain the desired image. The image can be captured through an immobile eye within 5 seconds. If the baby is fussy, he or she may be given a few drops of a sugar (sucrose) solution on a pacifier for calming. Although the images can usually be secured through a normal pupil, if the pupil is found to be too small, two drops of Cyclomydril will be placed on the eye for dilation. This is the eye drop used everyday in the Eye Clinic and nursery to dilate the pupils of babies. The dilation will last for about 6 to 10 hours. After the test, the baby will return to the nursery or be discharged home as intended by the Neonatology Division. There is minimal risk associated with this investigation. The instrument is non-invasive and does not touch the eye. The babies will be swaddled and held by a nurse to prevent any contact with the machine. The eye drop to be used if needed for dilation has been used on babies at Harbor for about 30 years. It has been found to very safe. The fact that we will study only term (not premature babies) and will apply only two drops if needed should minimize any risk from the eye drop. An ethical issue to consider is that while the study will provide important information that will undoubtedly help babies in the future, it will probably not benefit the baby being studied. However, if the baby has an undetected retinal or optic nerve problem, the study may reveal it.

NCT ID: NCT01338389 Completed - Uveal Melanoma Clinical Trials

Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

Start date: June 25, 2012
Phase: N/A
Study type: Interventional

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present. Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans. The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.