1. Articles in category: Clinical Trials

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    1. " En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials

      " En Face " OCT's Contribution in the Detection of Macular Retinal Toxicity Signs Linked to the Chronic Treatment of Synthetic Antimalarials

      The maculopathy induced by the retinal toxicity of the synthetic antimalarials must be detected at the infra-clinical state, when it can still be reversible. Identifying early retinal anatomical changes has always represented (a challenge for medical interns, dermatologists, rheumatologists, and ophthalmologists). Currently, the gold-standard for its screening and its diagnostic is the multifocal electroretinogram (mfERG), however it is a long and tedious exam, offered by only few medical centers. It is recommended to find a simple non-invasive alternative, on a commonly used equipment. The study of the ellipsoid (junction line between, the external and internal photoreceptor segments) using optical coherence ...

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    2. Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease

      Optical Coherence Tomography in Patients With Acute Myocardial Infarction and Nonobstructive Coronary Artery Disease

      The purpose of this study is to evaluate the prevalence and morphological features of coronary plaques by means of OCT in patients with acute myocardial infarction but without any significant coronary stenosis at coronary angiography. In addition, cardiac magnetic resonance imaging (CMR) will be performed to assess the prevalence, location, and pattern of myocardial injury as well as other concomitant findings. As a secondary analysis, the association between the distribution and characteristics of coronary plaques detected on OCT and myocardial injury shown by CMR will be evaluated. In addition, a post-hoc survey regarding the potential modification of the interventional treatment ...

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    3. Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy

      Optic Disc, Macula, and Retinal Nerve Fiber Layer Measurements Obtained by OCT in Thyroid Associated Ophthalmopathy

      The aim of the study is to compare the measurements of retinal nerve fiber layer (RNFL), macula and optical disc parameters obtained by optical coherence tomography (OCT), and intraocular pressure (IOP) between the patients with thyroid-associated ophthalmopathy (TAO) and healthy controls.

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    4. Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

      Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

      The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

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    5. 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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    6. 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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    7. 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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    8. 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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    9. 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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    10. 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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    11. 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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    12. 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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    13. 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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    14. 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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    15. 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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    16. 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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    17. 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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