Optic Neuritis

Researchers are investigating the effects of an investigational cold treatment device called ETX-4143 on the eye's surface anatomy and inflammatory response in people with chronic ocular surface pain (COSP). This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eye's conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are developing a multicenter registry to collect and share data on pediatric patients who have undergone deep brain stimulation (DBS) for movement disorders such as dystonia, epilepsy, Tourette syndrome, and mood disorders. The study aims to improve understanding of DBS safety and effectiveness in children, as current data are limited and individual centers often have too few cases for strong research. This registry will support large-scale analyses and help refine DBS as a treatment option for hyperkinetic movement disorders in the pediatric population. The study involves gathering both retrospective and prospective clinical data from multiple pediatric centers. The registry will collect information on surgical techniques, patient outcomes, implant sites, and long-term effects of DBS. This collaborative data-sharing approach enables comprehensive evaluation of which patients benefit most from DBS and how it impacts their quality of life over time. Participants include children aged 0 to 18 years who have already received or are scheduled to receive DBS for neurological movement disorders. Data will be collected over five years to monitor safety, efficacy, and quality of life outcomes. The study does not involve treatment administration but focuses on gathering and analyzing clinical information. Parental or legal guardian consent is required for prospective participation.

This research aims to evaluate postoperative respiratory complications (PORC) in children with obstructive sleep apnea (OSA) who undergo (adeno)tonsillectomy. It combines data from two centers: University Hospital Antwerp and Heim Pal National Pediatric Institute in Hungary. The study examines how common these complications are and whether they vary according to different health conditions such as obesity, craniofacial malformations, Down syndrome, or neurological disorders that affect airway muscle tone. Data come from a retrospective analysis of electronic health records originally collected in two prospective studies. These records include children who had (adeno)tonsillectomy for OSA, with postoperative care following a set protocol. The study looks at factors like the obstructive apnea-hypopnea index, oxygen levels during sleep studies, age at surgery, and presence of other health conditions to understand their relationship with PORC and to help develop a management plan. Participants' information was collected without needing additional consent because it uses existing anonymized data. Researchers assess the prevalence of PORC within 24 hours after surgery and analyze how different factors affect this risk. This study does not involve new treatments but reviews existing data to improve postoperative care. The study includes children aged 1 to 18 years who had (adeno)tonsillectomy for OSA, with follow-up limited to the immediate postoperative period.

Researchers are investigating the feasibility of producing artificial vision in people who are blind by using a device called the Intracortical Visual Prosthesis (ICVP). This study aims to test the safety of the ICVP system and evaluate whether electrical stimulation of the brain's visual processing areas can create visual percepts. The study involves participants with no light perception or very limited vision who have been blind for at least one year and have a history of normal or near-normal vision in early life. The intervention involves implanting wireless floating microelectrode arrays (WFMAs) into the visual cortex on one side of the brain. These devices deliver wirelessly transmitted electrical stimulation intended to induce artificial vision. Each participant will have multiple WFMA devices implanted. After surgical recovery, participants will undergo weekly testing for one to three years to assess the ability of electrical stimulation to generate visual percepts and evaluate the device's safety and efficacy. Participants will attend regular testing sessions to measure visual perception responses to stimulation and monitor safety outcomes. Researchers will perform assessments from two weeks after surgery through the entire device use period, up to three years. The primary outcome is the safety of the WFMA-based cortical interface, while secondary measures evaluate its effectiveness at producing visual percepts. The study includes video and audio recordings, cognitive and spatial functioning tests, and MRI scans. Participant involvement may last up to three years, with ongoing monitoring throughout the study.

Researchers are investigating epilepsy-dyskinesia syndromes, which are rare genetic diseases causing both movement disorders and epilepsy in children. This multinational retrospective survey, supported by the International Parkinson and Movement Disorder Society, aims to collect detailed clinical and molecular data to better understand these conditions. The study focuses on identifying patterns in disease features, progression, and genetic links to improve knowledge and support precision medicine. The study collects previously recorded data from multiple countries, harmonizing information on clinical features, disease progression, age of onset, genetic variants, and coexisting neurological conditions. By standardizing this data, the survey addresses challenges in rare disease research like small, dispersed patient groups and inconsistent protocols. The goal is to build a shared clinical database and analyze how movement and seizure disorders relate at both clinical and molecular levels. Participants are children aged 0 to 18 years with diagnosed movement disorders linked to specific genetic variants. The study reviews existing medical records and genetic information without new treatments or interventions. Researchers will assess the disease spectrum, how movement disorders affect quality of life, and the effectiveness of symptomatic treatments over one year. The study encourages international collaboration to advance understanding and improve care for these rare conditions.

Researchers are conducting an observational prospective study to build a large-scale multiomic database of adult patients undergoing advanced imaging studies. The study focuses on using recently introduced photon counting CT scanners and high-field 3T MRI scanners to explore latent imaging information, called "opportunist features," which may provide new insights into disease risk and progression. This research aims to improve understanding of pathological mechanisms and enhance diagnostic and prognostic accuracy in fields such as oncology, neurology, pulmonary, and cardiovascular diseases. The study enrolls consecutive adults undergoing advanced imaging examinations at a single center using the Photon Counting CT scanner (Neaotom Alpha, Siemens) and 3T MRI (MR 7700, Philips). Imaging raw data along with conventional images will be stored. Clinical, demographic, and laboratory information, including genetic test results when available, will be collected at enrollment. Blood samples for lab analysis will be taken during contrast media administration when applicable. Annual updates through clinical visits, telehealth, or phone interviews will be conducted to gather follow-up clinical, lab, and imaging data over a 10-year period. Participants will be asked to provide informed consent and undergo routine imaging and clinical assessments as part of their standard care. Data collection includes questionnaires, interviews, and automatic record updates when examinations occur at the study site. Researchers will monitor the development of imaging signatures linked to disease prevention, diagnosis, and treatment. The primary outcome is the creation of a comprehensive multiomics archive to support broad scientific research, with yearly follow-ups for up to 10 years.

Researchers are evaluating a new handheld optical coherence tomography (OCT) device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patient’s eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.

Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.

Researchers are conducting a prospective, single-arm observational study to collect data from whole-body magnetic resonance imaging (WB-MRI) scans of up to 100,000 adult participants aged 18 and older across multiple clinical sites in the United States. The study aims to evaluate the accuracy of WB-MRI screening in predicting clinically significant diseases, including cancer, metabolic diseases, aneurysms, and neurologic disorders, in people interested in proactive and advanced preventive healthcare. Participants must meet specific inclusion and exclusion criteria to ensure safety and appropriate enrollment. Participants will undergo a whole-body MRI scan as the primary procedure of the study. The study does not involve any treatment but focuses on diagnostic imaging to detect and assess clinically significant diseases. The study plans to follow participants for up to 10 years to monitor and evaluate outcomes related to clinically significant disease diagnoses and oncological findings using established scoring systems such as the ONCO-RADS score. During the study, participants will provide clinical, demographic, and medical history information and complete consent procedures. Researchers will collect and analyze data from the MRI scans and track diagnoses over the follow-up period. The study includes safety monitoring to exclude individuals with contraindicated medical devices or conditions that could pose risks. Participation involves attendance at clinical sites for imaging and data collection, with long-term follow-up to assess health outcomes over up to a decade.