View clinical trials related to Endothelial Corneal Dystrophy.
Filter by:The goal is to develop a nationwide registry to track longitudinal clinical outcomes of and store imaging data related to numerous corneal conditions. There are two main objectives including the establishment of the first nationwide corneal transplant registry in the United States to include information related to the donor tissue, recipient, surgical procedure, and long-term clinical outcomes. Ultimately, this prospective data collection will allow us to determine prognostic factors for successful corneal transplantation and create an algorithm to guide clinical practice based on real world outcomes. The second objective is to collect and create a database of historical, de-identified optical coherence topography (OCT) and corneal topography images to ultimately develop artificial intelligence (AI) based diagnostic and prognostic algorithms for corneal disease and surgery.
Aim: Identify predictive factors of good results after primary Descemet's Membrane Endothelial Keratoplasty (DMEK) in Fuchs Endothelial Corneal Dystrophy (FECD). 82 patients (102 eyes) with Fuchs Endothelial Corneal Dystrophy (FECD) underwent DMEK between March 2016 and March 2018 were analyzed. Follow-up time was 12 months. The studied prognostic criteria were: pre-operative Central Corneal Thickness (CCT), CCT's delta between pre and D15 post-operatively, anterior mean keratometry, pre-operative endothelial cell density (ECD) and postoperative ECD at 6 and 12 months, pre-operative visual acuity, donors' and recipients' ages, recipients' sex, rebubbling and triple procedure (DMEK combined with cataract surgery).
Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the current practice of over-pressurizing the eye at the end of surgery. Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT) for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical protocol with current practice, where the eye is over-pressurized for a set period of time, in terms of surgical efficiency, clinical outcomes, and adverse events. Study design: International multicentre non-inferiority randomized clinical trial Study population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell dysfunction above the age of 18 years. Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients will be randomized for either the iOCT optimized surgical protocol or current standard surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups will be evaluated with iOCT at the end of surgery. Main study parameters/endpoints: The main study parameter is the rate of adverse events (particularly graft dislocations). Secondary parameters/endpoints are surgical time, the recovery of visual acuity and endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the extent/duration of surgical tissue manipulations. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of iOCT during surgery does not entail additional risk to the patient. Participants to this study will adhere to the standard of care after corneal transplant surgery. In addition, they will receive study specific measurements and questionnaires. The additional measurements and questionnaires will be combined with regular follow up moments.