Retinal Detachment

This trial studies patients with uncomplicated rhegmatogenous retinal detachment to compare two different timings of internal limiting membrane (ILM) peeling during eye surgery. The research aims to understand whether peeling the ILM during the first surgery or delaying it until the time of silicon oil removal affects outcomes. The study is randomized and triple-masked, led by Sohag University. Participants will receive 23-gauge pars plana vitrectomy (PPV) with silicon oil tamponade. They will be randomly assigned to one of two groups: Group A will have ILM peeling performed during the initial surgery, while Group B will have ILM peeling delayed until the silicon oil is removed. Both groups receive the same PPV and silicon oil treatment. During the study, patients will be followed from enrollment until three months after surgery to monitor for complications. The main outcome measured is the incidence of complications within this period. Participants will undergo regular postoperative evaluations to assess safety and treatment effects throughout the follow-up time. Total participation duration covers from surgery through three months post-operation.

This research aims to compare surgical outcomes and parameters between cataract surgeries performed using a new 3D imaging system called the NGENUITY4 3D Visualization System and the current standard binocular microscope in patients with high myopia. The study focuses on how differences in depth of field between these two systems affect factors during surgery and the results, including potential complications. Participants will have high myopia and significant cataracts requiring surgery. Participants will be randomly assigned to one of two groups: one group will undergo cataract surgery using the standard binocular microscope, while the other group will have surgery using the Alcon NGENUITY4 3D Visualization System. During surgery with the NGENUITY system, the surgeon wears 3D glasses and views the operation on a 3D screen. Both groups receive standard cataract extraction with phacoemulsification and intraocular lens implantation. Throughout the surgery, researchers will measure how often and how far the microscope focus is adjusted, the distance needed to focus from the corneal surface to the lens capsule, total operation time, and ultrasound energy used. After surgery, participants will be followed for three months to monitor vision, eye pressure, and any complications. These assessments will occur on day 1, week 1, month 1, and month 3 after surgery to evaluate safety and effectiveness of the two visualization methods.

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 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.

Age-related macular degeneration (AMD) and diabetic retinopathy are common causes of visual disability in older adults. Neovascular AMD (nAMD) leads to early loss of central vision. This research evaluates the effects of switching from ranibizumab to aflibercept treatment in eyes with treatment naive, recurrent, or persistent nAMD, as well as diabetic retinopathy cases. The study includes patients previously treated with ranibizumab for up to one year and aims to understand the visual and anatomical changes after this switch. Participants will receive aflibercept therapy, and the study observes patients monthly over 12 months. The trial includes groups such as AMD patients previously treated with Lucentis (ranibizumab), treatment naive AMD patients, diabetic macular edema (DME) patients previously treated with ranibizumab, and treatment naive DME patients. The focus is on monitoring responses to aflibercept in these different patient groups. Throughout the study, participants will undergo comprehensive eye exams including best-corrected visual acuity (BCVA) tests, reading performance, standard ophthalmic checks, optical coherence tomography (OCT), fundus imaging, fluorescein and indocyanine green angiography, microperimetry, and OCT-based optical angiography. Researchers will measure changes in vision and macular anatomy over a year. The study also tracks retreatments and requires patients to attend regular monthly visits for monitoring and assessments.

High myopia, a condition where the eye has a severe refractive error, is increasingly common worldwide and especially prevalent among students in urban China. This condition can lead to serious vision problems and complications such as cataracts, glaucoma, and macular degeneration. Pathological myopia, characterized by elongation of the eye and thinning of the retina, often results in posterior scleral staphyloma (PSS), which can severely affect vision and potentially cause blindness. Researchers are developing an intelligent multimodal screening system that combines advanced imaging technologies including the Optos non-mydriatic ultra-wide-angle laser scanning ophthalmoscope, B-scan ultrasonography, and optical coherence tomography (OCT). This system uses artificial intelligence to precisely identify and assess fundus diseases, focusing on pathological myopia and PSS. It also aims to create a vision prediction model to help doctors tailor diagnosis and treatment plans, predict vision decline, and improve early intervention. Participants will undergo comprehensive eye examinations using color fundus photography, B-scan ultrasound, and OCT imaging. Detailed baseline data including demographic information, health status, eye history, and ocular measurements will be collected. The study will gather data from October 2024 to April 2026, followed by AI modeling analysis from April to October 2026. This research supports improved prevention, diagnosis, and management of pathological myopia, and may enhance telemedicine services to reach remote populations.

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.