39 Clinical Trials for Various Conditions
During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device.
Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder. Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves. The purpose of this study is to see if non-invasive OCT technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.
This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.
Recent studies have shown that people with multiple sclerosis (MS) who also have diseases related to vascular health such as high cholesterol, high blood pressure, diabetes, cardiovascular disease, and others, may end up more disabled than people with MS who don't have those diseases. This has led to a growing interest in the role of vascular diseases in MS since they may provide another avenue of MS treatment. Some also think that vascular disease may even be a cause of MS. The back of the eye, the retina, is well-suited to studying vascular diseases as blood vessels can be seen even on routine examination of the eye by eye doctors. These specialists are used to seeing changes in retinal blood vessels due to diseases known to affect the eyes such as glaucoma and diabetes. Sophisticated techniques for examining the retina allow for not only visualization of blood vessels, but the rate of blood flow through the blood vessels as well. These blood flow changes are thought to come before changes in what the blood vessels look like, and so may be able to detect problems even earlier than routine examination of the retina by eye doctors. Retinal blood flow has never been carefully studied in MS. Given that MS affects the retina due to the late effects of inflammation of the optic nerve, or optic neuritis, the investigators expect to see altered blood flow in the retinal blood vessels of people with MS compared to healthy control subjects. If so, the investigators can then use retinal blood flow as a way to measure therapies that target vascular diseases in the MS population and determine if those therapies can alter the course of disease.
Years before someone experiences the symptoms of Alzheimer's disease, a compound called amyloid beta (Aβ) builds up in the brain. Excess Aβ - directly or indirectly - causes many of the symptoms of Alzheimer's dementia. However, recent studies of the FDA-approved drugs lecanemab (Leqembi®) and aducanumab (Aduhelm®) indicate that removing Aβ from the brain doesn't stop Alzheimer's. Clearly, there are other problems that need to be fixed. The investigators are interested in the cause of Aβ buildup. Non-neuronal support cells, called glia, keep neurons healthy by regulating water and nutrient levels for the neurons. They also help clear Aβ away from neurons. Maybe Aβ builds up when glia are unhealthy. Glia are very hard to study in the brain. Luckily, the light-sensing part of the eye - the retina - is an extension of the brain. The investigators study glia in the retina to learn about glia in the brain. To study retinal glia, the investigators take pictures of the retina with optical coherence tomography (OCT). OCT is safe, painless, and is used in many eye clinics to look at the structure of the retina. When the investigators take OCT pictures under a bright light, and compare those to OCT pictures collected in darkness, it gives the investigators information about glial function. In a study published in 2020 ("Optical coherence tomography reveals light-dependent retinal responses in Alzheimer's disease") the investigators showed that this functional OCT measurement was different in people with Alzheimer's dementia, compared to age-matched healthy adults. The goal of this observational study is to compare people at a pre-dementia stage of Alzheimer's disease to people who do not have any signs at all of Alzheimer's disease. By "pre-dementia stage", the investigators mean people who are either cognitively normal, or have mild cognitive impairment, but have had a medical test that shows the chemical beginnings of Alzheimer's disease. Members of the comparison group will also be cognitively normal, or have mild cognitive impairment, but had a medical test that shows utterly no signs of Alzheimer's disease. The main question this study, is whether functional OCT can tell these two groups apart. If so, that would: * Help build the case for glial health being important in the earliest stages of Alzheimer's, which in turn could lead to new treatment strategies, and * Suggest that functional OCT might be used as an early (pre-dementia) screening test for Alzheimer's disease Participants will: * undergo a brief eye exam (the investigators will not dilate pupils for this study) * undergo a paper-and-pencil cognitive test (to help verify "normal" or "mild cognitive impairment" status) * take brief one-page survey to collect demographic information (like age) * permit limited access to pre-existing medical or research records (to verify the presence/absence of the chemical beginnings of Alzheimer's disease) * take several OCT pictures of both eyes, in light and after 2 minutes of darkness (several rounds of images are taken) The expectation is that all study procedures will fit within 2 hours of one day.
The aim of this pilot study is to assess the ability of a new polarization sensitive optical coherence tomography system to obtain high-quality images of retinal birefringence.
The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Optical coherence tomography (OCT) is a 3D imaging technology that has seen wide adoption within ophthalmology. However, optical access to the retinal periphery remains a challenge for conventional OCT systems. The study team plans to innovate peripheral retinal OCT imaging technology by first developing the first robotic OCT system capable of autonomously assisting the operator during imaging of the human peripheral retina using 3D active tracking and compensation and then by developing of the first OCT system designed for treatment of the retinal periphery.
The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes.
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.
Optical Coherence Tomography (OCT) image data will be evaluated for image quality and used to test post-processing algorithms to improve detection sensitivity for ophthalmic diseases.
The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula). OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves. The purpose of this study is to see if non-invasive OCT technology can changes due to retinal vein occlusions as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT. These studies will be evaluated to see how they relate to vision loss.
The purpose of this study is to determine whether phase variance optical coherence tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (FA), the current gold standard diagnostic test.
The basic objective of this project is to test a modification of existing technology for monitoring the responses of the pupil to light as a method for detecting regional losses of function of the retina. The "instrument" consists of a commercially available set of goggles that monitor the eye positions and pupils using infrared light and small cameras. The signals from the monitoring cameras are collected in a computer that records how their pupils have responded to each lighting condition. Because diabetics develop damage initially to certain parts of the retina before they have more serious damage, the ultimate goal of this research is to develop a simple, noninvasive, rapid method for widespread screening of diabetics in order to identify those who may require medical attention and/or therapy for diabetic retinopathy.
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.
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an established imaging technique use for eye exam in clinical ophthalmology, provides high-resolution cross sectional images of the retina and has increased our ability to understand many eye diseases.
The purpose of this study is to determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO).
This study, conducted at the NIH Clinical Center and the University of Wisconsin University, will compare measurements obtained using older and newer models of a machine called an optical coherence tomography (OCT) scanner. This instrument uses a beam of light to measure the thickness of the retina, the light-sensitive inner lining of the back of the eye. OCT measurements will be done in multicenter clinical trials of new treatments for disorders that cause vision loss, such as macular edema. Because some centers in these studies will use the older OCT model and some the newer one, it is necessary to determine whether the two models give comparable results. People 18 years of age and older in the following categories may be eligible for this study: * People with diabetes, with or without macular edema; * People with other retinal disease, such as uveitis or vein occlusion in the retina; * People with no history of eye disease who have a normal retina. Participants will have the following tests and procedures: * Eye examination to assess vision and eye pressure and to evaluate the retina. The pupils are dilated with drops for this examination. * Stereoscopic color fundus photography to examine the back of the eye. Eye drops are used to enlarge the size of the pupils to allow for a through examination and photographs of the eye using a special camera that flashes a bright light into the eye. * OCT to measure retinal thickness. For this procedure, the subject sits in front of a small screen and looks at a target in the center of the screen while a dim red light moves across the subject's retina. This test is done first with one model of the OCT scanner, then the other. Finally, the test is repeated in both eyes with whichever model was used first. Patients who are being treated for macular edema will repeat the same tests at their 3-month visits.
Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).
Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye imaging. The purpose of this study is to investigate the use of a novel long-working distance swept source (SS) optical coherence tomography imaging system with fixation alignment for use first in young adults, older children, and then young children ages 6 months to 6 years. The investigator's future goal is to obtain important retinal and optic nerve information from OCT in clinic in these young children.
This study will evaluate the total blood flow in the retina and choroid (structures in the back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography. Angiography is mapping of the blood vessels. The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare diseases in these structures causes a change in blood flow compared to healthy eyes and 2.) find out if areas of changed blood flow line up with areas of damage that appear on conventional testing.
This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.
The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.