1. Articles in category: Clinical Trials

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    1. Micell Technologies Completes Enrollment in OCT Study Designed to Evaluate Superior Performance of MiStent SES Compared to Xience

      Micell Technologies Completes Enrollment in OCT Study Designed to Evaluate Superior Performance of MiStent SES Compared to Xience

      e/ -- Micell Technologies, Inc . announced completion of enrollment in the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) Optical Coherence Tomography (OCT) study. The study will compare changes in coronary arteries between six and 24 months following treatment with MiStent or XIENCE V Everolimus Eluting Coronary Stent System (Xience). The clinical investigation and data analysis are being conducted by Cardialysis and the European Cardiovascular Research Institute (ECRI), in Rotterdam, The Netherlands. The OCT study will evaluate 60 patients randomized to MiStent or Xience. A prior MiStent clinical study has shown essentially no increase in late lumen loss between ...

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    2. Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials

      Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials

      Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already irreversible and the clinical picture may even continue to deteriorate for several years after the end of synthetic antimalarial use. In opposition, the early termination of hydroxychloroquine in patients showing recent alterations on the multifocal electroretinogram (nfERG) allowed he reversibility of toxic damage over a six month period. It is therefore critical to detect early retinal anatomic changes during retinotoxicity screening before the occurrence of irreversible anatomical and functional consequences. The usual patient ...

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    3. High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

      High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

      A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. There are different tools to correct them, like spectacles, contact lenses, and refractive surgery. Many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. In the present study we want to investigate the variability and reproducibility ...

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    4. SD-OCT Multimodal Analysis in GLaucoma

      SD-OCT Multimodal Analysis in GLaucoma

      Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions people affected in 2010. It is defined as a neurodegenerative disease characterized by a progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity, its impact on quality of life and an existing treatment that can delay visual field damages, there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve head excavation performed either by ophthalmologists or glaucoma specialists is highly inter-observer dependent and limits its ...

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    5. Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds (OPTICO-BVS)

      Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds (OPTICO-BVS)

      Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS. The hypothesis of the present ...

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    6. Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases

      Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases

      During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM), pseudomaculaforamen, maculaforamen and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM. Different study groups showed that ...

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    7. OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

      OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

      Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH. In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.

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    8. SD-OCT Angiography

      SD-OCT Angiography

      The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. The investigators will image study participants who have retinal diseases with the AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of the information contained in images obtained on AngioVue. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the AngioVue light source is well below maximum ...

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    9. Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

      Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

      This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.

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    10. Assessment of Cardiac Allograft Vasculopathy by Optical Coherence Tomography

      Assessment of Cardiac Allograft Vasculopathy by Optical Coherence Tomography

      Cardiac allograft vasculopathy (CAV) is characterized by marked intimal proliferation and concentric vascular thickening and fibrosis. CAV remains the leading cause of late morbidity and mortality in heart transplant recipients. Optical coherence tomography (OCT) is a new generation catheter-based modality that acquires images at a spatial resolution of 10-20 μm which is 10-fold greater than that of intravascular ultrasound (IVUS). OCT is currently the most sensitive imaging technique for early CAV detection. Recent studies proved that circulating human leukocyte antigen (HLA) directed donor-specific antibodies correlate with increased mortality and CAV. Contradiction of scientific results has been reported regarding increased resting ...

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    11. Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease

      Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease

      The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.

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    12. Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

      Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

      The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS) and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes requiring percutaneous coronary intervention. Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure followed by aspirin alone, while patients in the EES group will be treated with DAPT, at least for 6 months post procedure. In addition, this study will collect initial information about the safety and effectiveness of the BAS in comparison with EES group at ...

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    13. Measurement of the Distance Between the Limbus and Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography

      Measurement of the Distance Between the Limbus and Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography

      Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion measurement using calipers (gold standard).

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    14. Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration

      Vision Outcomes Using Quantitative Optical Coherence Tomography Evaluation in Age Related Macular Degeneration

      The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.

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    15. Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT)

      Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT)

      Background and study aims : The investigators conducted this study to evaluate the movement of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT. Who can participate? patients who underwent typical lateral rectus recession surgery for correcting intermittent exotropia What does the study involve? Volunteers will attend a clinic for four visits over six months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT. What are the possible benefits and risks of participating? This is non-invasive test for your postoperative ...

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      Mentions: Samsung
    16. Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

      Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

      This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.

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    17. 3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture

      3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture

      Achieved formalin-fixed paraffin embedded tissue specimens from colon cancers and/or other benign and pre-cancer colon lesions as well as melanoma and/or other benign pigmented skin lesions will be used. The achieved specimens were kept in Department of Pathology, National Taiwan University Hospital. Sections of achieved pathological specimens were put on glass slides and tissue image will be observed by 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution ...

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    18. Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

      Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

      The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

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    19. Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

      Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

      This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast- conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

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    1-24 of 233 1 2 3 4 5 6 7 8 9 10 »
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