Oxford

Researchers are evaluating the DRISTi artificial intelligence (AI) program as a tool to screen and diagnose Diabetic Retinopathy (DR), including its types such as mtmDR, PDR, and DME, in people with diabetes. The study invites participants diagnosed with diabetes mellitus who meet certain criteria to consent to have images of their eyes taken. These images will be analyzed by the DRISTi AI software and compared with evaluations from an ophthalmic reading center to determine the accuracy of the AI program in diagnosing DR. Participants will undergo fundus photography, where images of the back of the eye are taken and graded by the fully automated DRISTi AI device. The study focuses on assessing this diagnostic test to confirm whether DRISTi can effectively identify diabetic retinopathy signs. The study does not mention other treatment or intervention groups. During the study, participants' eye images will be collected and analyzed, with the main measure being the accuracy of the AI grading from the time of arrival to the completion of diagnostic tests, up to 8 hours. Participants must be available and willing to comply with study procedures and provide informed consent. Safety and eligibility will be monitored through inclusion and exclusion criteria. The overall participation duration depends on completing these diagnostic assessments.

Researchers are evaluating two surgical techniques for upper eyelid surgery, known as blepharoplasty, which removes excess skin to improve peripheral vision and appearance. This study uses a "split-face" design where one eyelid is treated with the traditional method involving a blade, cautery, and sutures, while the other eyelid is treated with a newer device called Ziplyft that compresses and seals the skin, eliminating the need for cautery and sutures. The study aims to compare bruising, wound closure, surgical time, and satisfaction from both patients and surgeons between these two methods. During the procedure, both eyelids will have the same amount of skin removed. The traditional side uses a blade and sutures to close the incision, whereas the Ziplyft side uses a clamp to compress the skin which stops bleeding and allows the use of tissue adhesive instead of sutures. The surgeon will record how long each side takes to operate. Postoperative photos will be taken on days 3 and 7 to assess bruising, and on days 7 and 30 to evaluate incision appearance. Patient and surgeon surveys will be collected to assess satisfaction with each method. Participants will be involved in follow-up visits to allow photo assessments and complete surveys regarding their experience. The study will monitor surgical case time from start to finish and track bruising, wound healing, and incision appearance up to two months after surgery. Both patient-reported outcomes and surgeon feedback will be evaluated throughout the post-operation period to compare these two surgical approaches.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.