Interrater Variability for the Identification of Anesthetic-induced Burst Suppression EEG
Burst SuppressionGeneral Anesthesia1 moreBurst suppression describes a specific EEG pattern that can generally indicate a too deep general anesthesia. The pathophysiology of anesthetic-induced Burst Suppression may be distinctly different from the pathophysiology of Burst Suppression from other medical causes (e.g., coma, hypothermia, intoxication). Definition criteria of neurologic societies cannot be applied to the classification of Burst Suppression during general anesthesia without adaptation. The lack of a clear definition complicates structured research on anesthetic-induced Burst Suppression EEG in the perioperative setting because of subjective bias. Therefore, a unified agreement on what anesthesia-induced Burst Suppression looks like is crucial to conduct the best possible research. The aim of this study is to formulate the basis for a clear definition of burst suppression EEG that may help to truly understand the significance of this EEG pattern and its relationship to proposed postoperative outcomes such as postoperative delirium, longterm postoperative neurocognitive disorders (PNDs) or increased mortality.
Performance and Safety Evaluation of the S360 Medical Device Software.
Binocular Vision DisorderBinocular Eye Movement Disorder1 moreThe aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360. This clinical investigation is performed in order to demonstrate the conformity of the medical device, when operating under the normal conditions of its intended use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device regarding the Medical Device Regulation (MDR) 2017/745 (EU).
Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance...
StrokeVisual Impairment7 moreThe goal of this clinical trial is to evaluate the effectiveness of an immersive virtual-reality (IVR) based stimulation program, in improving visual perception for people who have lost their driver's license due to perceptual or cognitive impairments. The main questions it aims to answer are: Can the 6-week IVR stimulation program help improve driving performance? Will participants experience improvement in visual detection and perception after training? Study Design Summary: Participants will be randomized into a waitlist group or intervention-first group The VR-based intervention will consist of training every 2 days for six weeks Waitlist group will wait 6 weeks before starting intervention at study midpoint (week 7) Intervention-first group will begin with intervention (week 1-6) and then stop intervention at study midpoint Participants will complete tests related to driving performance, visual attention, and visual fields at the start of study, midpoint, and end of study Researchers will analyze data for changes from baseline in outcome measures.
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment...
Branch Retinal Vein OcclusionThe purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).
Study to Evaluate the Efficacy Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations...
Retinitis PigmentosaUsher Syndrome Type 27 moreThe purpose of this study is to evaluate the efficacy safety and tolerability of QR-421a administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene with early to moderate vision loss.
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
Visual Impairment Due to Diabetic Macular EdemaThis study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
Extension Study to Study PQ-110-001 (NCT03140969)
Leber Congenital Amaurosis 10Blindness9 moreSubjects completing participation in study PQ-110-001 (EudraCT 2017-000813-22 / NCT03140969) will be given the opportunity to enroll into the extension study for continued dosing if available data support current and/or future benefits for the subject. Study PQ-110-002 will provide long-term safety, tolerability, pharmacokinetic (PK), and efficacy data of QR-110.
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment...
Central Retinal Vein OcclusionThe purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
Neurolens Convergence Insufficiency Study
Binocular Vision DisorderConvergence Insufficiency1 moreTo understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Convergence Insufficiency. It is a Prospective randomized double masked two arm performed on a minimum of 100 to a maximum of 150 subjects identified as symptomatic (CISS questionnaire score equal to or greater than 16) done across 3-10 clinical sites. There are two subgroups: a minimum of 50 in each subgroup(subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects(41-60 years).
Prevalence of Visual Dysfunction in Neurological Disorders
Parkinson DiseaseOther Neurological Disorders1 moreThe objective is to determine the prevalence of visual dysfunction in People with Parkinson's Disease (PwP). The investigators will administer the: Visual Impairment in Parkinson's Disease Screen and Revised-Self-Report Assessment of Functional Visual Performance. Patients seen at Fixel Institute and their caregivers will be invited to participate. Responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in PwP compared to those both with and without other neurological conditions.