Brecksville

This research aims to evaluate the rate of malposition and related clinical problems of the Hydrus Microstent device within 24 months after surgery in patients with primary open angle glaucoma. Participants will have an operable, age-related cataract and a diagnosis of glaucoma treated with up to four eye pressure-lowering medications. The study is a prospective, non-randomized, single-arm clinical trial sponsored by Alcon following acquisition of Ivantis, Inc. Participants will undergo uncomplicated cataract surgery using standard anesthesia and phacoemulsification, followed by implantation of a commercially available monofocal intraocular lens (IOL) and placement of the Hydrus Microstent device through the trabecular meshwork into Schlemm's canal. The Hydrus Microstent is a crescent-shaped nitinol device designed as a permanent implant to help fluid drainage in the eye. The study involves a screening visit, surgery on Day 0, and eight follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. Researchers will monitor the occurrence of clinically significant device malposition and any related clinical effects during this 24-month postoperative period. Assessments will include visual acuity, intraocular pressure, optic nerve appearance, and other protocol-defined evaluations to ensure safety and device performance.

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.