Rock Island

Researchers are evaluating the safety of the IC-8 Apthera intraocular lens IOL after treatment for posterior capsular opacification PCO, a common complication following IC-8 Apthera IOL implantation. This prospective, multi-center, non-randomized study focuses on patients who have already received the IC-8 Apthera IOL and now require NdYAG laser capsulotomy for PCO. The study aims to verify post-market safety following training in a standardized laser treatment technique. Participants previously implanted with the IC-8 Apthera IOL and experiencing PCO will be treated with NdYAG laser capsulotomy using a sponsor-recommended method. There is one study group, and subjects will be followed for 24 months after their IC-8 Apthera IOL implantation. The study includes about six visits over this two-year period to monitor safety and treatment outcomes. During the study, participants will undergo assessments of laser treatment outcomes, any complications, and IOL-related evaluations. Researchers will track additional laser treatments, secondary surgical interventions, ocular and serious adverse events, and subjective visual disturbances using specific questionnaires. The study lasts for two years post-implantation, with regular visits to ensure thorough monitoring of participant eye health and treatment effects.

Researchers are investigating whether using a catheter-based endovascular device called the WATCHMAN to close off the left atrial appendage can help prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral blood thinners. This study is a multicenter, randomized controlled trial with an open-label design but with blinded assessment of results to ensure unbiased evaluation. Participants will be randomly assigned to either receive the left atrial appendage occlusion with the WATCHMAN device or continue their standard medical care without the device. Those in the device group will undergo the procedure to close off the left atrial appendage using the WATCHMAN device. Both groups will continue their oral anticoagulant treatment as prescribed. The study will continue until 265 primary events of ischemic stroke or systemic embolism occur, with an average follow-up estimated at about 4 years. Throughout the study, participants will be monitored for occurrences of ischemic stroke, systemic embolism, transient ischemic attacks, cognitive function using the Montreal Cognitive Assessment, cardiovascular and all-cause mortality, and new disabling ischemic strokes. Safety and effectiveness will be assessed during the event-driven study period. Participants will be followed for approximately 4 years on average to gather the necessary outcome data and ensure ongoing monitoring of their health status.