Amblyopia (Lazy Eye)

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.

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups: one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone; the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are studying adaptive optics, a new imaging technology, to improve the diagnosis, treatment, and management of eye diseases affecting the retina. The study involves both people over age 12 with various eye diseases and healthy volunteers over age 12 to compare retinal images between diseased and normal eyes. The goal is to find better ways to detect retinal problems earlier than current methods allow. Participants will undergo eye exams including pupil dilation and adaptive optics imaging, where they look into a special instrument that captures high-resolution images of the retina. Some may also have additional tests like perimetry, color vision tests, and electroretinograms using numbing eye drops and special contact lenses. This observational study plans to enroll a total of 600 participants over five years, with 350 having eye diseases and 250 healthy volunteers. During the study visits, participants will provide medical and eye history and information about their medications. Researchers will assess the adaptive optics images qualitatively and quantitatively to compare normal and diseased retinal states. The study includes regular eye exams and imaging assessments, with the primary outcome focused on evaluating these adaptive optics images. Participation involves one or more visits, with detailed eye examinations and imaging procedures to monitor retinal health.

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.

This research aims to evaluate the effect of at-home amblyopia treatment with Curesight12 for children aged 8 to 12 years who have residual amblyopia. Amblyopia, or lazy eye, is a vision disorder where the brain doesn't process images well from one eye, leading to decreased vision. While treatments like glasses and patching help younger children, many older children still experience vision problems, so new treatments for this age group are needed to improve quality of life and reduce lifelong vision risks. The treatment uses the Curesight12 system, which includes an 11.6-inch tablet, an eye tracker, red-cyan glasses, and software that streams videos with special visual effects to encourage the amblyopic eye to work better. Children watch videos of their choice at home while the system blurs part of the stronger eye's view to stimulate the weaker eye. The device adjusts the blur based on each child's vision, and the study will assess how effective this approach is for older children aged 8 to 12. Participants will be involved for at least 12 weeks, during which researchers will measure improvements in the visual acuity of the amblyopic eye compared to their starting vision. The study includes eye exams and vision tests to monitor progress and to adjust the treatment as needed. Data is securely stored and managed following privacy standards. This pilot study follows previous trials in younger children and aims to provide insight into Curesight12's benefits for this older age group.

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 effectiveness of augmented reality (AR) training compared to traditional patching for treating unilateral amblyopia in children and adults aged 5 to 55 years. This trial addresses challenges with patching, such as poor adherence and limited improvement in visual functions, by using an innovative binocular therapy based on neural deficits seen in amblyopia. The study aims to compare improvements in visual acuity and other visual functions between the two treatments. The trial involves two groups: one receiving dichoptic AR training using a dual-pathway push-pull method targeting specific neural pathways, and the other undergoing conventional patching therapy. AR training requires patients to perform 2 hours of visual exercises daily at home using a device that presents different images to each eye, while the patching group patches the fellow eye for 2 hours daily at home. The study is conducted across multiple centers and based on advanced neural processing theories to rebalance visual pathways and binocular interaction. Participants will be assessed over 13 weeks with multiple evaluations at 2, 4, 9, and 13 weeks to monitor changes in visual acuity, stereopsis, contrast sensitivity, and treatment compliance. Safety reports are also collected regularly. The main outcome measured is the total effective rate at 13 weeks. Participants need to attend visits and complete treatments as scheduled to contribute to the study’s findings on improving visual outcomes in amblyopia.

Researchers are studying the community of microbial organisms living on the surface of the eye, known as the ocular microbiome, to understand its role in eye health and disease. This observational study aims to identify the normal bacteria present, factors that encourage their growth, and how these microbes may protect against or contribute to eye conditions. The study responds to the need for a comprehensive database describing the ocular microbiome in a healthy population. Participants will be grouped based on their eye health status, including those with normal eyes, mild glaucoma, non-infectious keratopathy, dry and wet age-related macular degeneration, and diabetic retinopathy. The study involves collecting samples through simple swabs of both eyes to analyze microbial DNA and other components using advanced sequencing methods over a three-year period. During the study, participants will undergo regular collection of eye swab samples and associated clinical data such as demographic information, medications, and allergies. Researchers will track changes in the ocular microbiome and assess its composition and function using advanced genetic sequencing techniques. The primary outcome is to define the normal ocular microbiome, with secondary outcomes focusing on sequencing methods. Participation includes follow-up visits over several years to monitor these factors.

Strabismus is a condition where the eyes do not align properly on a focused object, caused by issues such as congenital or acquired factors and affecting eye movement. It can lead to symptoms like diplopia or confusion in adults, while children may compensate for misalignment without diplopia. This research investigates how strabismus surgery impacts balance and postural control, building on limited prior studies that suggest surgery may improve balance by affecting eye muscle sensory functions. Patients with either congenital or acquired strabismus will be enrolled and divided into two groups accordingly. All participants will undergo comprehensive eye and orthoptic examinations along with balance assessments before surgery and at 30, 90, and 180 days after the surgical procedure to correct their eye alignment. Throughout the study, participants will be evaluated at multiple time points with tests measuring eye function and balance, including dynamic balance and various vision tests. The primary outcome is the change in dynamic balance from baseline at each follow-up. Secondary measures include detailed eye movement and binocular vision tests. Safety and ability to maintain balance for extended periods are also monitored during the six-month follow-up period.