Bermuda Run

Researchers are conducting a Phase 2 randomized, double-masked, multi-site clinical trial to evaluate the safety of Ex Vivo Corneal Cross Linking (CXL) of donor corneal tissue in patients undergoing high-risk penetrating keratoplasty. This study involves 96 participants with corneal transplant failure characterized by corneal neovascularization, aiming to determine safety outcomes over a 24-month period post-transplant. Participants will be randomly assigned to receive either donor corneal tissue treated with Photrexa4 Viscous and Photrexa4 combined with ultraviolet (UV) light for cross-linking, or untreated donor tissue as the control. The corneal tissue is prepared by a Corneal Tissue Bank following Current-Good-Tissue-Practice standards and then transplanted. The study compares cross-linked versus untreated corneal tissue in vascularized high-risk keratoplasty. During the study, participants will be monitored for up to 24 months after transplantation to track any adverse events related to the transplanted tissue. Assessments will include safety evaluations focused on the primary outcome of determining the safety of corneal cross-linking. Participants must comply with study visits and assessments throughout the entire follow-up period to support comprehensive safety monitoring.

Researchers are compiling real-world results of the Intracept™ Intraosseous Nerve Ablation System, which is a commercially approved device used to treat patients with vertebrogenic pain, a cause of chronic low-back pain. The study aims to understand how this minimally invasive procedure performs in everyday medical practice for those diagnosed with vertebrogenic pain syndrome. Participants receive treatment using the Intracept™ Intraosseous Nerve Ablation device according to local instructions for use. This procedure is designed to address vertebrogenic back pain by targeting affected nerves within the bone structure. The study focuses on patients who are already scheduled for this therapy in routine clinical care. During the study, researchers will observe participants over time and measure changes in disability related to back pain using the Oswestry Disability Index, with follow-up assessments reaching up to 60 months after the procedure. The study collects data on how patients respond to the treatment in real-world settings, aiming to gather long-term outcomes and safety information.