Brecksville

This research study aims to gather safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses IOLs, which are devices implanted in the eye during cataract surgery to restore clear vision after removal of the cloudy natural lens. The study focuses on patients diagnosed with bilateral cataracts, including those with astigmatism suitable for correction with toric IOL models. The lenses are intended to remain in the eyes for the patients lifetime. Participants will be implanted with either the Clareon TruPlus Monofocal Non-Toric or Toric IOL based on recommendations from an IOL calculator. The cataract surgery uses a minimally invasive technique called phacoemulsification to remove the natural lens before implantation. The study includes one preoperative visit, two surgical visits with the second eye surgery occurring 0 to 14 days after the first, and five postoperative visits, spanning approximately 13 months of participation. Throughout the study, participants will undergo assessments of binocular photopic best corrected distance visual acuity BCDVA at preoperative day 0 and at 1, 3, and 12 months after surgery. Researchers will monitor vision outcomes and the performance of the implanted lenses. The study involves regular follow-up visits and evaluations to ensure participant safety and to collect detailed data on visual acuity over time.

This research aims to evaluate the rate of malposition and related clinical outcomes of the Hydrus Microstent within 24 months after implantation. The study focuses on adults aged 45 and older who have primary open angle glaucoma and an operable cataract. Participants will undergo cataract surgery combined with the placement of a monofocal intraocular lens IOL followed by Hydrus Microstent implantation. Participants will have the Hydrus Microstent implanted immediately after cataract surgery and IOL placement. The cataract surgery uses standard anesthesia and phacoemulsification techniques. After surgery, participants will attend follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 to monitor outcomes. Throughout the study, participants will be evaluated for device positioning and any associated clinical consequences. Researchers will assess the occurrence of device malposition, intraoperative ocular adverse events, and sight-threatening or other postoperative ocular events up to 24 months after surgery. This schedule of visits and evaluations aims to gather comprehensive safety and performance data over a two-year period.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.