Preparation and Planning for the Prospective Randomized Image-guided Ophthalmic Surgery Clinical Trials

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Project Summary Image-guided surgery with intraoperative optical coherence tomography (OCT) has the potential to have a significant impact on surgical efficiency, patient quality-of-life, surgical safety, and overall surgical outcomes in two common surgical vitreoretinal disorders: macular hole and epiretinal membranes. OCT has revolutionized the clinical management of retinal diseases. The high-resolution cross-sectional information that is provided by OCT now is the mainstay for evaluating anatomic distortion, confirming diagnosis, and gauging prognosis for an extensive list of retinal conditions, particularly vitreoretinal interface disorders, such as macular hole and epiretinal membranes. Utilizing OCT to provide surgical guidance and feedback is a natural extension of this technology. Multiple prospective studies suggest that intraoperative OCT may have a significant impact on surgical decision-making, including key metrics in surgical efficiency (e.g., reducing unnecessary surgical manipulations). This research activity will focus on developing two clinical trials focused on establishing the role of intraoperative OCT in vitreoretinal macular surgery and will be led by Justis P. Ehlers, MD, of the Cleveland Clinic Cole Eye Institute. Dr. Ehlers is a highly trained retina surgeon with extensive experience in the field of intraoperative OCT and in clinical trial execution. Dr. Ehlers has led multiple clinical trials, including the successful completion of his own investigational new drug (IND) trial and the 2 largest prospective clinical research studies on intraoperative OCT completed to date. This 2-year planning grant will facilitate optimal clinical trial design, team-building, and infrastructure support needed to execute these trials with success and efficiency. This R34 clinical trial planning activity will focus on 2 primary surgical procedures: image-guided epiretinal membrane peeling and macular hole repair with individualized positioning based on intraoperative OCT feedback. Although unique, these 2 trials have significant overlap that facilitates designing both trials under this single R34 activity. The 2 trials will utilize the same sites, research coordinators, and investigators. These resource overlaps will greatly enhance the efficiency of protocol development and developing safety protocols. Utilizing nearly a decade of experience with intraoperative OCT and clinical trial execution, Dr. Ehlers is well-equipped to lead this clinical trial team. In order to enable the successful execution of this activity and the subsequent clinical trials, Dr. Ehlers has assembled a group of experts in the field of clinical research, vitreoretinal surgery, biostatistics, imaging, and value-based medicine. These experts will form the Image-guided Surgery Study Group to facilitate successful planning and trial design over the course of these 2 years. In addition to this group of experts, Dr. Ehlers has also developed strong partnerships that will facilitate the success of these clinical trials. The primary goals of these clinical trials will be to evaluate image-guided surgery with intraoperative OCT for its role in personalized surgery and to define the role for intraoperative OCT in macular surgery based on surgical efficiency, outcomes and value. !