93 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the use of fluorescence imaging + Indocyanine Green (ICG) dye ("Firefly"), compared to standard white light imaging in 2D and 3D, for accurate visual diagnosis of endometriosis during a da Vinci robotically guided endometriosis resection procedure.
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
1. To evaluate the accuracy of virtual visual field (VVF) headsets equipped the standard visual field software in its ability to assess visual function in various retinal, glaucoma and neuro-ophthalmic disorders by comparing retinal fundus and optic nerve images, optical coherence tomography and neuroimages to the VVF produced. 2. To test the null hypothesis that VVF testing compares favorably to the gold standard, Humphrey visual field (HVF) by comparing testing time, mean sensitivity, markers of reliability including false positives and negatives and fixation losses and global indices such as mean deviation and pattern standard deviation.
In this study, we will use behavioral methods to investigate several types of interactions that occur when visual stimuli conflict, such as when objects are presented nearby to each other, or to separate eyes. We will target purely sensory aspects by using simple geometric shapes: letters and lines. Our outcome measure will be performance thresholds.
Group 4a and 4b was an FDA trial that showed that patients who have an Amsler grid abnormality on paper, have a similar abnormality on the app. Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version. Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula (vision is 7/10th of a line better on the app).
The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.
The primary objective of this study is to determine if the diagnostic performance of DaTscan™ single photon emission computed tomography (SPECT) imaging is different in non-Caucasian subjects compared with Caucasian subjects with movement disorders.
In this proposal the investigators have three Specific Aims using human patient populations as model systems; 1) identify a role for the Basal Ganglia (BG) in perceptual decision making; 2) determine whether the Basal Ganglia contribute to decision making under conditions of visual uncertainty; 3) determine whether the cerebellum plays a role in perceptual decision-making under conditions of visual uncertainty. The investigators designed experiments using healthy humans and humans with diseases known to affect the Basal Ganglia and the cerebellum, Parkinson's Disease, dystonia and non-dystonic cerebellar damage. With this approach the investigators will test the following hypotheses: 1) Patients with Parkinson's Disease and dystonia will have more difficulty than healthy controls making perceptual decisions when faced with sensory uncertainty; when sensory information is certain, patients will show improved decision-making but will still be impaired relative to healthy humans. Hypothesis 2: If ambiguous sensory information is aided by prior information, patients with Parkinson's Disease and dystonia will be unable to use the prior (bias/memory) information to inform their decisions. Hypothesis 3: Deep Brain Stimulation (DBS) of Basal Ganglia structures will improve the ability of patients to use prior information to inform their decisions when faced with sensory uncertainty. Hypothesis 4: Both cholinergic and dopaminergic medical therapies will improve the ability of patients to use prior information to inform their decisions. Hypothesis 5: Patients with non-dystonic cerebellar damage will be similar to healthy controls in performance of a perceptual decision making task in conditions of visual uncertainty. The overarching framework of this application is that the same mechanisms (D1 striatal synaptic plasticity) that operate in reward learning play a role in learning and using stimulus priors in a perceptual decision-making task when faced with uncertainty. Because Parkinson's Disease and dystonia share deficits in striatal circuitry, the patient deficits on this task will be similar. Because non-dystonic cerebellar patients do not have dysfunction of striatal circuits, they will show no deficits in the ability to use stimulus priors to guide choices in uncertain conditions. In the event these patients do show deficits, this is will provide evidence for an unexplored role for the cerebellum in perceptual decision-making.
The 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.
This is an outpatient, multicenter, prospective, pivotal, double-blind, within-subject comparison trial of the Marcus Autism Center Investigational Device (MAC-ID) diagnostic procedure relative to the gold-standard (reference standard), current best practice expert clinician diagnosis (ECD) of Autism Spectrum Disorder (ASD) in children 16-30 months of age. Consecutive pediatric patients from the intended population (i.e. children 16-30 months of age) recruited from pediatric referrals and general advertisements will be the subjects of this trial. All subjects will undergo the MAC-ID diagnostic procedure (test). All subjects will also undergo the current best practice clinical diagnostic procedure, using standardized ASD diagnostic instruments and standardized developmental assessments, to produce the ECD of each child's ASD status (reference/gold standard). The study consists of a screening phase and diagnostic evaluation phase to assess the validity (sensitivity and specificity), safety, and effectiveness of the MAC-ID when used to diagnose ASD. Subjects will be enrolled in the trial for a period of 1 day. The trial will be completed in approximately 12 months. The overall study objective is to assess the safety and effectiveness of the MAC-ID to accurately diagnose ASD (primary analysis), as well as to accurately assess severity of ASD (secondary analysis) in very young pediatric subjects. The primary endpoints of this study are the diagnostic result from the MAC-ID and the diagnostic results from the ECD evaluation, both of which are either positive or negative for ASD. Each subject will undergo the Social Developmental Testing Device procedure and an examination by a clinical expert in the field of ASD diagnosis; all study center site personnel (including the expert clinicians responsible for the ECD evaluation) will be blinded to MAC-ID results.
The effect of tinted filters and illumination on the visual performance of patients with low vision (i.e., individuals with reduced vision that is uncorrectable with glasses, surgery or treatments) has been a topic of research and discussion for many years, yet there is no current consensus or practice standard for the evaluation and recommendation of colored filters and/or illumination intensity. Anecdotally, there have been many subjective reports of improvement in visual function and comfort with the use of tinted lenses. Previous studies have attempted to elucidate the subjective improvements observed using vision tests, such as visual acuity and contrast sensitivity, and the findings have been inconsistent. Traditionally, filters and optimal illumination are prescribed clinically through a trial and error method, which involves trying various filters and lamps haphazardly to determine which if any are preferred by the patient. The investigators are proposing to evaluate whether the illumination and filters chosen in office by participants using a new assessment tool the LuxIQ/2 translate to overall patient comfort and improved speed, accuracy and print size while reading, and to evaluate whether participants have the same illumination and colored filter preference determined by the LuxIQ/2 in a clinical office setting and in their home environment. The investigators will evaluate whether participants prefer lighting determined by the new assessment tool the LuxIQ/2 in comparison to lighting determined by the OttLite Cobra in office.
The goal of this clinical study is to learn about the utility and performance of the EarliPoint System (™): Evaluation for Autism Spectrum Disorder to diagnose and assess autism spectrum disorder (ASD) in children ages 31-96 months (2.5 - 7 years chronological age). The main questions it aims to answer are: 1. To determine the sensitivity and specificity of the EarliPoint device (test) compared to Expert Clinician Diagnosis (ECD) using gold-standard clinical reference assessments in the target age-expanded population. 2. To determine the association between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 3. To determine the association between the EarliPoint Nonverbal Ability Index score and the clinical measures of non-verbal abilities as measured by the Differential Ability Scales (DAS-II). 4. To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score. 5. To determine the association between the EarliPoint Expressive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 6. To determine the association between the EarliPoint Receptive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 7. To estimate the incidence of adverse device effects associated with the use of the EarliPoint device.
The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.
The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).
Objective. Bipolar Disorders (BD) are a major public health problem. The investigators still lack knowledge of the mechanisms which contribute to BD. Hence treatments are few and limited, and clinical decision making is less refined. Currently, the investigators are investigating the effects of midday bright light therapy for the treatment of bipolar depression (University of Pittsburgh IRB approved protocol titled Light Therapy for Bipolar Disorder, IRB#: PRO09020546). In this study, the investigators propose to investigate a possible biological mechanism which might explain response to light treatment in depressed bipolar patients.
This study aims to identify novel markers of psychosis using electroencephalography (EEG).
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.
People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Central vision loss primarily results from eye diseases or disorders that affect the macular region of the retina, such as age-related macular degeneration (AMD) and Stargardt disease. The clinical wisdom is that exaggerated fixational eye movements are detrimental to vision. This forms the basis of the increasing number of clinical trials that use fixation stability (variability of eye positions during fixation) as an outcome measure to evaluate the effectiveness of interventions on age-related macular degeneration or other retinal diseases, despite the lack of causal evidence supporting or refuting a relationship between fixational eye movements and functional vision. If excessive fixational eye movements are indeed detrimental to vision for people with central vision loss, can we reduce the amount of their fixational eye movements, thus improve their fixation stability? And if so, does that lead to improved functional vision? The goal of this study is to examine the hypothesis that retinal image motion due to abnormal fixational eye movements can be modified through fixation training, with accompanied improvements in functional vision as a result.
Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice. The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.
Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder.
The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
Postural instability, freezing-of-gait (FOG), and falls are among the greatest unmet needs in Parkinson disease (PD). FOG eventually affects more than half of people with PD, and is notoriously difficult to treat pharmacologically or via deep brain stimulation. Visual cues do improve gait freezing, but their efficacy and adoption is limited because they are not practical to use in all real-world situations. There is a need for a cueing technique that is on-demand and discreet - only perceptible to the patient. Fortunately, recent technological advances in augmented-reality (AR) enable such an approach. In this study, state-of-the-art AR glasses will be used to project digital cues that are only visible to the wearer, to determine if they can improve FOG. 36 individuals with PD and FOG will be recruited to perform an obstacle-course gait task under six cue conditions: no cue, conventional cue, constant-on AR, patient-hand-triggered AR (turns on when patient clicks button), patient-eye-triggered AR (turns on when looking down), and examiner-triggered AR. The AR cue is a set of images that appear on the floor at a patient's feet, mimicking floor lines. Gait performance will be captured on video and via body-worn wireless sensors that detect how each limb is moving. The investigators will determine whether individuals are cue-able with conventional visual cues, whether intermittent cues outperform constant-on cues, and whether cues triggered by an examiner outperform cues triggered by patients themselves.
The investigators plan to examine the relation of perceptual variables-basic vision, unusual perceptual experiences(including but not limited to visual hallucinations)-to relevant functional variables such as cognition, mood, and alertness/sleepiness in an online sample of persons with Parkinson's disease (PwPD). It is hypothesized that unusual perceptual experiences will relate significantly to the selected variables. Participants do not need to experience visual hallucinations to be able to participate in this study. This is an observational study only, and not an interventional study.
The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test. The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants. Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.
The visual system has increasingly been recognized as an important site of injury in patients with schizophrenia and other psychoses. Visual system alterations manifest as visual perceptual aberrations, deficits in visual processing, and visual hallucinations. These visual symptoms are associated with worse symptoms, poorer outcome and resistance to treatment. A recent study using brain lesion mapping of visual hallucinations and identified a causal location in the part of the brain that processes visual information (visual cortex). The association between visual cortex activation and visual hallucinations suggests that this region could be targeted using noninvasive brain stimulation. Two case studies have found that brain stimulation to the visual cortex improved visual hallucinations in treatment resistant patients with psychosis. While promising it is unclear whether these symptom reductions resulted from activity changes in the visual cortex or not. Here we aim to answer the question whether noninvasive brain stimulation when optimally targeted to the visual cortex can improve brain activity, visual processing and visual hallucinations. The knowledge gained from this study will contribute to the field of vision by providing a marker for clinical response and by personalizing treatment for patients with psychosis suffering from visual symptoms. This grant will allow us to set the foundation for a larger more targeted study utilizing noninvasive brain stimulation to improve visual symptoms in patients with psychosis.
This research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.