57 Clinical Trials for Various Conditions
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.
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 purpose of this research study is to compare the effect of Latanoprostene Bunod and Timolol on eye pressure and blood vessels of the back of the eye.
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.
Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal vessels. The loss of this vascular response may lead to retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic retinopathy. The long-term goals of this project are to determine whether decreased blood flow in diabetic patients and the resulting retinal hypoxia contributes to the development of diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows or prevents the development of retinopathy.
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.
Diabetic complications are an important source of blindness and mortality among Veterans. Their occurrence is unpredictable because of the highly variable effect of factors such as weight, diet and exercise. Improved prediction of diabetes complications has the potential to improve the care for Veterans with diabetes, especially if this can be done without any extra effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are required to undergo annual retinal photography to screen for current diabetic retinopathy. The investigators have recently developed an automated, precise, fast, novel tool for measuring retinal vessels in these images. Manual measurement of retinal vessels has shown that these can predict future -not current- development of hypertension and also diabetic retinopathy. If the investigators can confirm that their tool can flag those Veterans at increased risk for developing these diabetes complications, this will allow earlier intervention and prevention. Because the tool only uses the images that are being taken anyway, there is no extra effort for either the Veteran or VA staff.
We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma. The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.
This study will compare the safety and effectiveness of two treatments-injections of triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO). Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug Administration has approved it for injection into joints and muscles to treat inflammatory conditions. Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18 months' duration may be eligible for this study. Candidates are screened with a medical history, blood pressure measurement, and urine pregnancy test for women who can become pregnant. Screening also includes the following procedures: * Eye examination to assess visual acuity and eye pressure, and to examine the cornea, lens, and retina. The pupils are dilated with drops for this examination. * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. * Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. The patient is seated in front of a machine and looks at a pattern of flashing and rotating red and green lights, first with one eye and then with the other. * Fundus photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the retina are taken using a camera that flashes a bright light into the eye. Participants are randomly assigned to receive triamcinolone injections or standard treatment. Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy when they enter the study may have it later if blood clears enough to permit treatment. The procedures for triamcinolone injections and laser therapy are as follows: * Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is injected into the vitreous, the jelly-like substance located between the back of the lens and the retina. Patients apply antibiotic drops at home for 3 days following the procedure. * Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is placed on the eye during the laser beam application. All patients are followed every 4 months for 3 years. Additional visits may be scheduled if needed. Patients who receive triamcinolone injections are also examined within 1 week of each injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye examination and fundus photography. Optical coherence tomography is done at some visits, and fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser therapy as often as every 4 months, depending on their response to treatment.
This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: * Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) * Macular edema associated with retinal vein occlusion (18 years of age and older) * Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: * Medical history and physical examination * Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. * Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. * Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. * Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. * Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
The purpose of this study is to evaluate this AngioScan angiography software on patients with various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically used camera, but the AngioScan angiography software is not FDA approved. Investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. Images collected in this study may be compared to other images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).
The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.
The RBBK study is a non-interventional, prospective study that will characterize disease state biomarker levels from aqueous humor, vitreous humor, intraoperative tissue and saliva of subjects with various retinal and systemic pathologies.
The research is designed as a randomized, 2-arm, parallel, controlled, human clinical trial to investigate the effects of avocado and mango consumption for 8 weeks on indices of macro- and micro- vascular function in individuals with prediabetes. FMD of the brachial artery, pulse wave velocity (PWV), central blood pressure (cBP), and Optical Coherence Tomography Angiography (OCTA) of the eye will be used for vascular assessments. The research plan will also explore cognitive and kidney function benefits of regular avocado and mango intake using specified cognitive tasks and kidney function biomarkers
The purposes of this study are: * To correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain. * To evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.
Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks.
The purpose of this research study is to see if high-speed weight training performed in a circuit (using one machine after another) can improve participant heart and brain function, strength, and power in older persons.
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.
Cerebral small vessel disease (SVD), present in 80-94% of adults over age 65 years, increases the risk of stroke by 2-fold, and dementia by 2.3-fold. There is currently no treatment to slow SVD progression. This study aims to test whether impaired cerebral and retinal vasoreactivity may serve as biomarker for SVD progression, and to evaluate the safety and efficacy of cilostazol (antiplatelet agent with vasodilatory and anti-inflammatory properties) for the treatment of SVD.
The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.
Background: Retinal hemangioblastoma (RH) is a tumor. It grows from the retina in the eye. It can threaten a person s vision. Trans-scleral cryotherapy is used to destroy the tumors and minimize the long-term risks of vision loss. RH is a rare condition, often occurring in people with von Hippel-Lindau disease. There are no clinical trials to study how well the treatment works. Researchers want to study the medical records of people with RH who were treated at the NIH eye clinic to learn more. Objective: To analyze clinical data collected over a 20-year span to study consecutive cases of RH managed with trans-scleral cryotherapy at the NIH. Eligibility: People who took part in NIH natural history protocols for which cryotherapy of RH was performed as a standard care measure. Design: Researchers will collect and study data from participants medical charts. Participants will not be contacted because no new data is needed. Researchers were granted a waiver of informed consent for use of these medical records. To protect patient privacy, participants will be assigned an ID number. Their data will be entered into a spreadsheet in a coded fashion. The key to this code will be kept in a secure file. No patient identifying information will be used in the analysis or the publication....
The 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).
The 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).
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.
The objective of this research is to determine the effects of anti-VEGF drugs (bevacizumab, ranibizumab or aflibercept) on aqueous humor dynamics (AHD) in patients with retinal vascular disease. The underlying hypothesis is that anti-VEGF drugs increase intraocular pressure (IOP) by increasing aqueous inflow, decreasing uveoscleral outflow or both. The specific aim is to evaluate the changes produced in AHD after 1 baseline and a subsequent 1 monthly injection of anti VEGF agents.