Rock Island

Researchers are investigating ways to improve treatment for hyperacusis, a condition where ordinary sounds seem too loud, annoying, scary, or painful. This study evaluates a new remote counseling program called Hyperacusis Activities Treatment (HAT) and compares two types of sound therapy to manage symptoms. The research aims to provide early clinical evidence on how these therapies may help people with hyperacusis by testing counseling delivered remotely and different sound therapy approaches. Participants first complete four weeks of remote counseling using videos, activities, discussion forums, and quizzes designed to educate about hearing and sound sensitivity. After counseling, participants are randomly assigned to one of two sound therapy groups for four weeks: one group listens to bothersome sounds gradually increased in volume, and the other listens to continuous low-level background noise using a tinnitus masker device. Both sound therapies are delivered remotely with devices fitted and used for 1-2 hours daily. During the study, participants undergo assessments at baseline, four weeks, eight weeks, and twelve weeks to measure changes in hyperacusis symptoms. Researchers use questionnaires, psychoacoustic tests, and surveys to evaluate symptom changes before and after counseling and sound therapy. Device data logging tracks therapy use and volume settings. The total participation includes monitoring, counseling, and sound therapy periods over twelve weeks, with the goal of determining the potential effectiveness of these treatments.

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 post-approval study is prospective, multi-center, and non-randomized, focusing on subjects who have previously received the IC-8 Apthera IOL and later developed PCO requiring Nd:YAG laser capsulotomy treatment. The study aims to monitor safety outcomes following this laser treatment using a standardized technique after sufficient surgeon training. Participants will receive the Nd:YAG laser capsulotomy treatment to address PCO in the eye with the IC-8 Apthera IOL. The study involves a single group of subjects, all having undergone prior IC-8 Apthera IOL implantation, with the other eye implanted with a monofocal or monofocal toric IOL. The study includes about six visits over a 24-month period following the IC-8 Apthera IOL implantation, during which safety and treatment outcomes will be assessed. During the study, subjects will be monitored for several outcomes including rates of additional Nd:YAG laser treatments, treatment complications, intraocular lens related assessments, secondary surgical interventions, serious adverse events, ocular adverse events, and subjective visual disturbances using specific questionnaires. Safety and effectiveness assessments will be conducted across the 24 months post-implantation, ensuring comprehensive evaluation of the IC-8 Apthera IOL after PCO treatment.

Researchers are evaluating the safety and effectiveness of Phentolamine Ophthalmic Solution in adults who have previously undergone keratorefractive surgery and experience reduced visual acuity in low light conditions. This phase 3 trial compares the effects of Phentolamine Ophthalmic Solution to a placebo to determine if the drug improves night vision. The study focuses on participants who report symptoms like glare, halos, or starbursts that began within two months after their surgery. Participants will be randomly assigned to receive either 0.75% Phentolamine Ophthalmic Solution or a placebo, both administered once daily for two weeks. During this period, participants will visit the clinic weekly for checkups and testing. They will also keep a daily diary to record when they apply the study medication each evening. Throughout the study, participants will undergo vision tests to measure changes in visual acuity under mesopic (low light) conditions. The main outcome is the percentage of participants who gain at least 15 letters (equivalent to 3 lines) improvement in vision at day 15 compared to the start. Researchers will monitor safety and collect data on any side effects. Participation involves regular clinic visits, vision assessments, and adherence tracking over the two-week treatment period.

Researchers are evaluating the safety and feasibility of the ELIOS System procedure to reduce intraocular pressure (IOP) in adults diagnosed with mild to moderate primary open-angle glaucoma (POAG). The study focuses on assessing how well this device works to lower eye pressure, which is important in managing glaucoma and preventing vision loss. Participants will receive treatment using the ELIOS System as a standalone procedure. The study does not mention additional comparison groups or alternative treatments. The procedure aims to decrease the IOP while participants continue the same or fewer glaucoma medications. Throughout the 12-month study period, researchers will measure the proportion of participants who achieve at least a 20% reduction in mean diurnal IOP from their baseline levels while on the same or fewer medications. They will also track the average change in IOP over this time. Monitoring will include assessments of eye pressure and safety to understand the procedure's effects over one year.

Researchers are evaluating whether catheter-based endovascular left atrial appendage occlusion can prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral anticoagulants. This multicenter, prospective, open-label randomized trial uses blinded assessment of outcomes to provide clear results. The study focuses on participants with persistent, permanent, or certain types of paroxysmal atrial fibrillation and elevated stroke risk. Participants will receive treatment using the WATCHMAN device to perform left atrial appendage occlusion through a catheter-based approach. This device-based intervention is compared to usual care with oral anticoagulants, which participants must have been taking for at least 90 days before enrollment. The study period is event-driven and will continue until 265 primary endpoint events of ischemic stroke or systemic embolism occur, with an estimated average follow-up of about 4 years. During the study, participants will be closely monitored for stroke or embolism events as the primary outcomes. The trial assesses the safety and efficacy of the procedure in addition to ongoing anticoagulant therapy. Participants must be able to provide informed consent and are followed throughout the study duration to evaluate these outcomes.