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Showing 1-20 of 117 trials
NCT04584125
This randomized clinical trial will assess corneal astigmatism and visual outcomes in participants who have undergone corneal transplantation for keratoconus with ex vivo cross-linked donor corneal tissue versus participants who have undergone corneal transplantation for keratoconus with non-cross-linked donor corneas. Crosslinking is a procedure that stabilizes the biomechanical properties of the cornea; as a result, the cornea stiffens. It has been shown that this procedure stabilizes the cornea of patients with keratoconus or corneal ectasias. The FDA currently approves crosslinking for patients with progressive keratoconus and corneal ectasia following refractive surgery. Ex vivo crosslinking of donor corneal tissue for patients with keratoconus undergoing PK or DALK could stabilize the cornea and reduce the risk of high astigmatism and improve vision in patient with keratoconus.
NCT06235567
This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.
NCT07468253
Observational study comparing patients with inter-eye asymmetric keratoconus with patients with inter-eye symmetric keratoconus.
NCT07444957
This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled. The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups. The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.
NCT04475380
Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.
NCT07372911
Keratoconus causes irregular astigmatism and reduced vision. Epi-off corneal crosslinking (CXL) stabilizes the cornea but often leaves higher-order aberrations uncorrected. This randomized, parallel-group trial compares corneal wavefront guided photorefractive keratectomy (corneal wavefront guided PRK, 50 µm therapeutic ablation) combined with accelerated epi-off CXL versus epi-off CXL with epithelial removal by phototherapeutic keratectomy (PTK) using a Schwind AMARIS excimer laser, in adults with keratoconus. The primary endpoint is change in best-corrected distance visual acuity (logMAR) at 12 months. Key secondary endpoints include Kmax, corneal higher-order aberrations, manifest refraction, Scheimpflug densitometry (haze) and Fantes grade, Corvis ST biomechanics, NEI VFQ-25, and endothelial cell density by non-contact specular microscopy at 1, 3, 6 and 12 months.
NCT06451718
This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
NCT04439552
Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo Confocal Microscopy (IVCM).
NCT00470587
The triage of patients with suspected acute coronary syndrome in the emergency room is a time-consuming diagnostic challenge. Therefore high sensitive early markers for myocardial damage are needed for more rapidly rule out of acute myocardial infarction (AMI) - especially for the first 3 to 4 hours after onset of chest pain in AMI ("troponin-blind" period). Therefore we test the hypothesis that the use meticulous patient history and novel cardiac markers can provide a faster detection or exclusion of AMI in patients presenting with acute chest pain to the emergency department. The prospective cohort study is designed to enrol patients presenting with acute chest pain at rest within the last 12 hours to the emergency department. Several blood samples for detection of the new markers will be drawn and compared with the gold standard for the diagnosis of AMI (high-sensitivity cardiac troponin T). All patients will be contacted by telephone at 3, 12, 24 and 60 months to determine functional status, major adverse cardiac events (death, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention), and the results of cardiac examination (stress test, coronary angiography) if performed.
NCT06818461
To evaluate corneal biomechanical changes using the Corvis ST in patients who have under-gone LASIK, PRK, and corneal cross-linking (CXL).
NCT00005216
To determine if silent myocardial ischemia was associated with an increased risk of cardiac mortality and morbidity during a one to three year follow-up in patients with coronary heart disease.
NCT02118922
We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.
NCT04094090
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
NCT07174206
The FAPO-2 study (Patient Monitoring Tool for Clinical Observation and Arrhythmia Detection) is a prospective, interventional, non-randomized study designed to evaluate the feasibility, usability, clinical effectiveness, and cost-efficiency of a wearable-enabled remote monitoring strategy in adult cardiac patients. The intervention consists of active clinical management of patients via teleconsultations, triggered by automated alerts generated through wearable data integrated into a centralized digital platform. FAPO-2 will include patients with chronic cardiovascular conditions and those undergoing recent minimally invasive interventions. The central objective is to validate a structured model for early arrhythmia detection, remote risk stratification, and timely clinical action. A total of 520 patients aged ≥22 years will be enrolled, stratified by sex (1:1), and followed at the Heart Institute (InCor) of the University of São Paulo. Participants will be allocated into one of four protocol groups: Group 1 - Pilot (n=15): Healthy volunteers monitored for \~14±3 days using both the smartwatch and a portable holter system to validate usability, skin tolerability, signal integrity, and data flow within the platform. Group 2 - Extensive Outpatient Monitoring (n=150): Patients with chronic cardiovascular diseases monitored over a 45-day period. During 30 days, monitoring will be performed using a smartwatch to capture blood pressure, oxygen saturation, heart rate, and single-lead ECG. For 15 days, participants will use both the smartwatch (for HR and ECG) and a portable holter system. Group 3 - Extensive Post-Intervention Monitoring (n=50): Patients recently undergoing procedures such as angioplasty, TAVI, or ablation, following the same monitoring protocol as Group 2. Group 4 - Optimized Outpatient Monitoring (n=305): Patients with stable chronic cardiac disease monitored for 15±3 days, using both devices simultaneously for HR and ECG (smartwatch) and portable holter system.
NCT03504800
This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions. The primary goal will be achieved by using optical coherence tomography (OCT) to: 1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities. 2. Develop OCT metrics for more sensitive detection of keratoconus progression. 3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
NCT04570020
The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.
NCT06450470
Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties. The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.
NCT06914973
The cornea, as the outermost refractive structure of the eye, plays a critical role in maintaining clear vision. Its transparency and structural integrity are essential for optimal visual function. Among the layers of the cornea, the corneal epithelium is of particular interest due to its dynamic nature and its ability to remodel in response to various physiological and pathological conditions. Accurate and repeatable measurement of corneal epithelial thickness (CET) is therefore crucial for diagnosing and managing corneal diseases, such as keratoconus, and for planning refractive surgeries Keratoconus, a progressive corneal ectatic disorder, is characterized by thinning and protrusion of the cornea, leading to irregular astigmatism and visual impairment. Early detection and monitoring of keratoconus rely heavily on precise corneal imaging, including CET mapping. While AS-OCT has shown promise in evaluating CET in both healthy and keratoconic eyes, the repeatability of these measurements must be thoroughly evaluated to ensure their clinical utility Early diagnosis with subsequent corneal crosslinking (CXL) can slow-down or stop keratoconus progression.9 Identifying subclinical keratoconus is extremely important in refractive surgery screening to avoid iatrogenic ectasia. Anterior and posterior corneal topography combined with total cornea thickness measurements and localisation of the thinnest area are the parameters used commonly for diagnosing and staging of corneal ectasias. Recently, epithelial thickness is also added as an additional parameter and is shown to be useful for both early diagnosis and grading of keratoconus Corneal imaging is an essential tool in modern eye care. Initially, the curvature of the anterior corneal surface constituted the ground for the estimation of corneal optical properties and diagnosis of ectatic disorders like keratoconus. Gradually the importance of the posterior corneal curvature as well as its thickness gained significance. In recent years, new imaging devices allowing fast and high-resolution imaging of the entire anterior segment, cornea included started to emerge. The main advantages of the new generation Anterior Segment Optical Coherence Tomography (AS-OCT) are their superior acquisition speed, improved optical resolution (axial and transversal), as well as scanning depth and field of view . High-resolution imaging of the cornea with AS-OCT provides thickness measurements individually for epithelium and stroma individually. Measuring corneal epithelial thickness adds information that could be of value in early diagnosis, progression evaluation and maybe even for a more complete understanding of the pathophysiology of this disease. It has been shown that changes in the corneal epithelial thickness could be a sensitive tool for early keratoconus detection as well as for the assessment of the disease progression. Precise measurements of the epithelial thickness are therefore important for keratoconus diagnosis and follow-up. AS-OCTs have high axial resolution and studies have shown that these instruments provide repeatable epithelial measurements both in central and peripheral cornea. With an additional lens (anterior segment module), posterior segments OCTs can also be used to measure corneal parameters including epithelial thickness1and previous studies have shown that these modules can also produce precise epithelial thickness measurements in healthy corneas and in keratoconus. There is only limited information on how the precision of epithelial measurements with the anterior module in posterior segment OCTs compares to the precision of epithelial measurements with AS-OCTs Aim of this study Detect early-stage keratoconus by identifying suitable epithelial thickness changes before topographic abnormalities appear . \- Provide higher accuracy compared to traditional topography by offering high-resolution cross-sectional imaging
NCT04667572
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
NCT04427956
Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.