Retinopathy

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Diabetic Macular Edema (DME) is a complication of diabetes that causes swelling in the central part of the retina, leading to vision loss. This condition results from changes in the small blood vessels of the retina, causing leakage and retinal thickening, often linked to increased levels of vascular endothelial growth factor (VEGF). DME is a common cause of blindness in people with diabetes, and it is especially significant in Bangladesh due to the high number of adults living with diabetes. This study compares the effectiveness and safety of two treatments for DME: a proposed biosimilar of Ranibizumab and Lucentis, both given as 0.5 mg injections into the eye every four weeks. A total of 70 adults with DME will be randomly assigned to receive one of these treatments in three doses over eight weeks. Safety visits will occur 48 hours after each injection, and the study concludes with an evaluation visit at week 12. Participants will undergo vision tests and imaging of the retina at the start and end of the study to measure changes in visual acuity and retinal thickness. Safety will be monitored throughout with follow-up visits shortly after each injection. Researchers will track how many patients maintain or improve their vision and assess any side effects. The total participation time for each patient is approximately 12 weeks.

Researchers are studying the ACUSURGICAL Luca System in a prospective, open-label, single-center trial in Belgium to treat vitreoretinal diseases such as intravitreal hemorrhage and macular pucker. This study involves up to 15 participants undergoing vitreoretinal surgery, with only one eye per subject enrolled. The study focuses on evaluating the safety of this surgery system over a three-month period. Participants will undergo vitreoretinal surgery supported by the Luca System under general anesthesia. The study includes patients who are pseudophakic or aphakic, aged between 18 and 85 years, and who require vitrectomy to address specific eye conditions. The trial is monocentric and non-controlled, meaning all participants will receive the same surgical intervention without comparison groups. During the study, participants will have follow-up visits to monitor safety outcomes and assess visual function. Researchers will evaluate safety measures over three months after surgery. Participants must be able to comply with scheduled visits and have health insurance. The total participation duration is centered around surgery and post-operative monitoring within this timeframe.

Researchers are investigating outer retinal diseases, which affect parts of the eye such as photoreceptors, the retinal pigment epithelium, basement membrane, or choroid. The study aims to collect detailed retinal images using adaptive optics to develop new diagnostic tools, biomarkers, and clinical endpoints. Both healthy volunteers and individuals with these diseases are included to support the comparison and understanding of retinal changes over time. Participants will undergo imaging with advanced adaptive optics devices that combine scanning laser ophthalmoscopy and optical coherence tomography. These systems capture high-resolution videos of retinal cells while correcting for eye-related distortions. Imaging will focus on several key areas in the macula and will be repeated over a three-year period to track changes in retinal cell structure and function. During the study, participants will receive imaging sessions where measurements such as photoreceptor density, retinal pigment epithelial cell density, organelle movement, and photoreceptor function will be recorded. Some measurements will be repeated to assess consistency. The study monitors these cellular features to better understand disease progression and to aid future therapy development. Participation may last up to three years with periodic imaging visits.

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.

Researchers are evaluating whether an ambulatory stroke unit model (aSU) is not worse than conventional inpatient stroke unit care (SU) for patients aged 60 years or older who have had an acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia with mild or no lasting neurological problems. This study aims to see if outpatient care can be a medically safe and resource-efficient alternative to hospital care in managing these types of strokes in older adults, with attention to clinical outcomes, patient quality of life, and health care use. Participants are randomly assigned to one of two groups. One group receives ambulatory stroke unit care involving a comprehensive same-day multiprofessional assessment, diagnostic evaluation, and start of secondary prevention treatments, followed by discharge home if stable. The other group receives standard inpatient stroke unit care with hospital admission, monitoring, and diagnostics according to clinical guidelines. The main comparison is based on patients' functional outcome 90 days after treatment. During the 90-day study period, researchers evaluate functional status using the modified Rankin Scale, monitor for early neurological worsening, recurrent strokes, delirium, mortality, and serious adverse events. They also assess health-related quality of life, mobility, stroke impact, healthcare use, and treatment costs. Outcome assessments are done by blinded evaluators, and some measurements continue up to 12 months. The study explores the feasibility and acceptance of ambulatory stroke care to inform future health service planning.

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 developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Researchers are evaluating the use of arterial spin labeling (ASL), a non-invasive MRI technique, to measure blood flow in the retinal tissue and the human eye. This study focuses on testing the precision and specificity of the MRI protocol for accurately measuring regional blood flow (rBF) and cerebral blood flow (cBF) without the need for contrast injections. The study includes both healthy volunteers and patients with retinal diseases such as thyroid associated orbitopathy (TAO), inflammatory optic neuropathy (ION), and ischemic optic neuropathy. Participants will undergo an MRI scan using the ASL technique as described in the study protocol. The study groups include healthy volunteers with normal vision, chronic patients with decreased visual acuity from the specified diseases, and patients in the acute phase of these diseases who will be examined again in the chronic phase. The study is non-randomized and does not involve masking or placebo controls. During the study, participants will have MRI assessments to measure blood perfusion in the retina at various time points, including repeatability measurements in volunteers over 2 months and perfusion measurements in patients during acute and chronic phases over 4 years. Researchers will monitor the safety and tolerability of the MRI procedure and observe changes in retinal blood flow. Participation involves following the study protocol and signing informed consent, with ongoing evaluation of retinal perfusion as the primary outcome.

This research aims to evaluate the effectiveness of Brief Cognitive Behavioral Therapy delivered via telehealth in reducing suicidal thoughts and attempts among people with physical disabilities. The study focuses on individuals who have experienced suicidal ideation recently or have attempted suicide within the past month. It is designed to better understand how this non-medication therapy works for people with vision, hearing, or mobility impairments. Participants will receive 12 sessions of Brief Cognitive Behavioral Therapy, specifically adapted for those with physical disabilities. These sessions are conducted remotely through telehealth, allowing participants to engage from their own location. The therapy schedule typically spans around three months. Throughout the study, researchers will measure changes in suicidal thoughts weekly using a specialized scale and assess self-injurious behaviors during the treatment period. Participants will be evaluated regularly to monitor progress and safety. The total study duration includes treatment completion, with ongoing assessments during this time to understand the therapy's impact.