Kingston

Researchers are investigating the effects of APL-3007 combined with SyfovrePegcetacoplan APL-2 in patients with geographic atrophy caused by age-related macular degeneration AMD. This Phase 2 randomized, placebo-controlled study aims to assess the efficacy, safety, tolerability, and pharmacodynamics of these treatments in this eye condition. The study involves multiple centers and uses a masked design to ensure unbiased results. Participants will be assigned to one of three groups two receiving different doses or frequencies of APL-3007 in combination with pegcetacoplan APL-2, and one receiving a placebo along with pegcetacoplan APL-2. The study will evaluate the treatments given as multidose regimens. The treatments focus on complement C3 inhibition to potentially impact disease progression. Throughout the study, participants will undergo assessments including artificial intelligence-based imaging to measure retinal pigment epithelium lesion area and photoreceptor degeneration, safety evaluations through adverse event reporting and visual acuity tests, and blood tests to assess serum markers. These evaluations occur over 12 months to monitor changes from baseline. Participants involvement includes regular visits for these assessments, with the study tracking treatment effects and safety over the duration.

Researchers are evaluating whether low energy selective laser trabeculoplasty SLT is as effective as standard energy SLT for treating glaucoma and ocular hypertension. The study aims to determine if repeating low energy SLT once a year can better prevent or delay the need for daily eye drop medications compared to waiting for the effects of standard SLT to wear off before repeating it. This is a phase 3 randomized clinical trial sponsored by the University of Pittsburgh. Participants initially receive either standard energy SLT, where energy levels are adjusted to produce champagne bubbles every 2nd or 3rd spot during a 360-degree treatment, or low energy SLT, delivering 100 spots at 0.4 mJ per spot with energy adjustments based on bubble formation. After 12 months, eligible participants are randomized to either annual repeat low energy SLT or as-needed repeat standard energy SLT. One treatment arm was discontinued following an interim analysis. Throughout the study, participants are monitored at regular intervals up to 48 months to track outcomes such as 12-month and 48-month treatment survival, mean intraocular pressure IOP at multiple time points, and occurrence of IOP spikes. The study involves assessments of eye pressure and glaucoma progression, with follow-up visits scheduled to observe long-term effects and safety. Total participation may extend up to four years, including repeated evaluations and treatments.

This research aims to evaluate patient and surgeon-reported outcomes for individuals undergoing blepharoplasty using a device called Ziplyft. The study focuses on measuring patient satisfaction with facial appearance and eyes, surgeon satisfaction and efficiency, bruising, eyelid symmetry, wound closure success with tissue adhesive, and case time. The study is interventional and monitors these outcomes over a 3-month period following the procedure. Participants will receive treatment with Ziplyft, a Class 1, 510k exempt device designed to remove excess unwanted eyelid skin through a novel surgical method. The procedure is performed once, followed by regular follow-up visits extending up to 3 months to assess various outcomes including the success of wound closure and improvements in eyelid appearance and symmetry. Throughout the study, participants will attend scheduled visits for evaluations that include patient and surgeon feedback, assessments of bruising and eyelid symmetry, and measurements related to wound healing and procedure efficiency. Researchers will track these factors from enrollment through the final visit at 3 months to understand the devices performance and participant satisfaction. Participants are also monitored for any adverse effects and are expected to comply with study instructions and follow-up visits during this time.

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.

This research study focuses on people who wear contact lenses but find it uncomfortable to wear them for long periods due to dry eye symptoms. The study aims to evaluate whether using Lacrifill regularly over a 2 to 3 month period can help people wear their contact lenses longer without discomfort and reduce signs and symptoms of dry eye. Lacrifill is a drug being studied for its potential to improve comfort for contact lens users with dry eye. Participants in this trial will use Lacrifill, a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage to keep the eyes bathed in natural tears. This is a single-arm study without a comparison group, and the treatment will be used over 2 to 3 months. The study will monitor the effects of Lacrifill on dry eye symptoms and contact lens tolerability during this period. During the study, participants will be assessed through various questionnaires and clinical tests to measure dry eye signs, symptoms, and contact lens wear time. These include the CLDEQ-8 and OSDI questionnaires, tear break-up time, corneal staining, and Schirmers tear test. Safety and tolerability will be closely monitored throughout the study. The total participation time is about 2 to 3 months, with results focusing on changes in dry eye and contact lens comfort.