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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating two commercially available trifocal toric intraocular lenses to compare their clinical outcomes and patient satisfaction in people undergoing cataract surgery. The main goal is to compare the distance-corrected intermediate visual acuity provided by these lenses. Additionally, the study aims to assess and compare the safety of the two trifocal toric intraocular lenses designed to correct astigmatism and improve vision at near, intermediate, and distance ranges. Participants will be randomly assigned to receive one of two types of trifocal toric intraocular lenses Optiflex TRIO or AcrySof IQ PanOptix. Both lenses are single-piece, posterior chamber foldable intraocular lenses with advanced aspheric optics and a trifocal design intended to reduce dependence on glasses. The Optiflex TRIO features a refractive-diffractive trifocal toric optic with a square edge design, while the AcrySof IQ PanOptix has a diffractive trifocal optic with a toric component. Each participant will receive one of these lenses based on randomization during cataract surgery. During the study, participants will be monitored for visual acuity outcomes, focusing on binocular distance-corrected intermediate vision at six months after lens implantation. Researchers will also track patient satisfaction and safety throughout the study period. The study includes preoperative assessments such as corneal topography or keratometry to measure astigmatism and will involve follow-ups to evaluate visual performance and any adverse effects. The total duration of participation varies but includes at least a six-month follow-up for outcome measurement.

Age: 21Years +All GendersPhase Not Applicable
6 locations
S

Actively Recruiting

This research investigates the use of a novel biological graft, Spongioflexae, for partial meniscal replacement in patients with symptomatic, degenerative, and irreparable damage to the medial or lateral meniscus. The study aims to assess whether this new implant can avoid or delay the disadvantages associated with previous replacement materials and reduce the need for total knee arthroplasty TKA. Since no current alternative biological material exists, this trial holds significant medical and economic importance. Previous research shows that successful meniscal repair improves clinical knee function and MRI imaging outcomes. Participants who choose surgery will receive the Spongioflexae implant during an arthroscopic procedure, where a demineralized allogenic bone block is fitted to the meniscal defect and secured with sutures. Surgery lasts 60 to 90 minutes with a hospital stay of 2 to 3 days. Patients who opt not to have surgery will be closely monitored and may join the operated group later. Follow-up visits occur at hospital discharge, 6 weeks, 6, 12, 24 months, and 5 years after implantation. Throughout the study, participants undergo evaluations including MRI scans to assess meniscal size, extrusion, and cartilage condition, as well as clinical knee scores like KOOS, IKDC, and VAS pain measured at multiple time points. Safety is monitored by recording adverse events. Patient satisfaction questionnaires are also completed. The research team tracks the procedures effectiveness in preventing or delaying the progression to knee replacement, with total participation lasting up to 5 years.

Age: 18Years - 60YearsAll GendersPhase 4
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety and initial effectiveness of mesenchymal stromal cells MSCs derived from umbilical cord tissue to treat cartilage damage in the knee joint. This prospective, multicenter, single-arm, open-label clinical trial focuses on patients with symptomatic cartilage defects who are candidates for surgical cartilage regeneration. The study aims to provide detailed safety data and early efficacy outcomes over a two-year period following treatment. Eligible patients will undergo arthroscopic or minimally invasive knee surgery during which the investigational product, called MesemCart, containing 10 to 20 million UC-MSCs applied to a collagen carrier, will be placed once directly on the cartilage defect. All participants receive this same treatment and are followed up regularly for 24 months. The study includes a single treatment arm without any placebo or comparison groups. Participants will be monitored through scheduled visits up to two years after surgery to assess safety, including serious adverse events, and to evaluate cartilage regeneration using imaging scores and patient-reported outcomes. These outcomes include pain levels, knee-related quality of life, symptoms, stiffness, activities of daily living, and physical resilience during sports, measured at 12 and 24 months. Safety will be tracked continuously, with all adverse events documented and assessed throughout the study.

Age: 18Years - 60YearsAll GendersPhase 1Phase 2
7 locations