1. Articles in category: Clinical Trials

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    1. Changes in Amblyopia Using Optical Coherence Tomography

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      Changes in Amblyopia Using Optical Coherence Tomography

      There have been multiple trials to investigate the morphological changes in the macula and retinal nerve fiber layer of amblyopic eyes, due to the different published results and the lack of evident association between these changes and the patients' parameters. So, we perform this study to compare the variations in macular parameters (central thickness, average thickness, macular volume) and peripapillary thickness in different cases of amblyopic eyes versus the normal fellow eyes using spectral-domain optical coherence tomography . In addition, to estimate the relationship of optical coherence tomography variations with different defined patients' parameters (age, sex, best corrected visual acuity, spherical ...

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    4. Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

      This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.

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    5. Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis

      Explore Home - ClinicalTrials.gov Dermatology , Clinical Trials
      Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis

      Amyloidosis is caused by the misfolding protein accumulated in tissue, which affects the function of the organs. In addition to the primary cutaneous amyloidosis, a skin lesion may also appear in another classification - systemic amyloidosis. Physicians can confirm diagnosis of the above classification by skin biopsy. Primary cutaneous amyloidosis is common in Asia and South America. In Taiwan, 80 people are diagnosed with primary cutaneous amyloidosis in every 100,000 people. Among the disease, macular amyloidosis and lichen amyloidosis are the most common subtypes. Primary cutaneous amyloidosis can cause severe itching, pigmentation, and skin keratosis, and further affect the social ...

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      Mentions: Apollo Medical Optics

    6. Multicentre Registry of CCTA, IVUS and OCT

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Multicentre Registry of CCTA, IVUS and OCT

      The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.

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    7. Early Feasibility Study: Application of OCT Imaging in Dermatology

      Explore Home - ClinicalTrials.gov Dermatology , Clinical Trials
      Early Feasibility Study: Application of OCT Imaging in Dermatology

      Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture biological images from within optical scattering media (e.g., biological tissue). A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use. Apollo Medical Optics, Ltd. (AMO)'s product originated at National Taiwan University (NTU), when AMO's researchers first began investigating medical optics. Apollo Medical Optics has developed a platform-based OCT tissue scanning system (B100) and have been conducting studies at the Mackay Memorial Hospital, Taipei as well as the Memorial ...

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      Mentions: Apollo Medical Optics

    8. Choroidal Thickness in Beta-thalassemia Patients

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      Choroidal Thickness in Beta-thalassemia Patients

      The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls. An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.

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      Mentions: Patras University

    10. Comparison of Coronary Lithoplasty and Rotablation

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Comparison of Coronary Lithoplasty and Rotablation

      Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure ...

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    11. Treatment of Periodontal Disease in Systemic Lupus Erythematosus

      Explore Home - ClinicalTrials.gov Dentistry , Clinical Trials
      Treatment of Periodontal Disease in Systemic Lupus Erythematosus

      Many studies have conducted to evaluate the relationship of systemic inflammatory diseases with periodontal disease. Previous evaluations suggest that there is no significant association between patients with Systemic lupus erythematosus (SLE) and Periodontitis (PD). However, some of the studies have shown relevancy between these two inflammatory diseases and have suggested to explore more for further knowledge. The aim of the study is to establish and investigate a relationship between SLE and PD. The study which will take place in two centers and will recruit 30 patients which will enter a pilot randomized controlled trial. Individuals enrolled into the study will ...

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    12. OCT Feasibility Older Hip Fracture

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      OCT Feasibility Older Hip Fracture

      Optical coherent tomography (OCT) is a device used to achieve cross-sectional imaging of tissues. It is often used in ophthalmology and also has application in dermatology, cardiology and other specialities. Usually, in adults, a table-top device is used necessitating the transfer of patients to the location of the device. In children a hand held device is used meaning the device can be taken to the patients' location. To facilitate/ help design a future study, this study's aim is to assess the feasibility of achieving retinal imaging in older people who are recovering from hip fracture surgery using a hand ...

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    13. Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea

      Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults. Compared to the general population, OSA occurs more often in patients with coronary artery disease (CAD), with a reported prevalence of 38% to 65%. Emerging evidence indicates OSA initiates and exacerbates coronary atherosclerosis. Moreover, several observational studies indicate the presence of OSA was associated with higher rate of restenosis and repeat revascularization (mainly attributed non-culprit lesion revascularization) after percutaneous coronary intervention (PCI). OSA might initiate endothelial injury by repetitive bursts of sympathetic activity that occur with apneas and hypopneas. Moreover, untreated OSA reduces endothelial repair capacity. Whether OSA ...

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    14. Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Explore Optical Coherence Tomography News Cardiology , Clinical Trials , Other Business News
      Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the 50 th patient enrolled in its INSIGHT clinical trial. The INSIGHT trial is a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris ® Lumivascular atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries. Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist, noted, “We are pleased to have the first 50 cases completed as part of our INSIGHT IDE study. Early ...

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      Mentions: Avinger

    15. Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

      A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

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    17. Physiology & Optical Coherence in STEMI

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Physiology & Optical Coherence in STEMI

      The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology & Imaging guided PCI in patients with STMEI. A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons. STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.

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    18. NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

      Primary objective: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients. Secondary objectives: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients. To evaluate patient experience when self-operating the Notal-OCT V2.5.

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      Mentions: Notal Vision

    19. Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

      Explore Home - ClinicalTrials.gov Neurology , Ophthalmology , Clinical Trials
      Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

      The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.

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    20. Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

      Explore Home - ClinicalTrials.gov Neurology , Ophthalmology , Clinical Trials
      Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

      The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

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    21. Apelin as a Potential Treatment for Chronic Kidney Disease

      Explore Home - ClinicalTrials.gov Urology , Clinical Trials
      Apelin as a Potential Treatment for Chronic Kidney Disease

      Chronic kidney disease (CKD) affects 8-16% of the world's population, and is independently associated with cardiovascular disease (CVD). As renal function declines, rates of major adverse cardiovascular events, cardiovascular and all-cause mortality increase. In addition to hypertension, increased arterial stiffness is characteristic of CKD, a marker of CVD risk, and an independent predictor of mortality in CKD patients. The endothelium is an important regulator of arterial stiffness, and endothelial dysfunction is a feature of CKD and a predictor of CVD. Current treatment of CKD is limited and aims to reduce blood pressure and proteinuria through the use of angiotensin ...

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    22. Role of Intracoronary Imaging in Plaque Identification

      Explore Home - ClinicalTrials.gov Cardiology , Clinical Trials
      Role of Intracoronary Imaging in Plaque Identification

      NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.

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      Mentions: Boston Scientific St. Jude Medical

    23. Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC) (OPACITY)

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC) (OPACITY)

      Optical Coherence Tomography Angiography (OCT-A) is a noninvasive imaging technique that allows one to see blood vessels in the retina. The investigating team used this approach in patients with acute, recurrent and persistent subtypes of Central Serous Chorioretinopathy (CSC) to check for possible Choriocapillaris hypoperfusion. The presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. The possibility of a correlation between Choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. This study was conducted in an effort to improve one ...

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    24. Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.

      Explore Home - ClinicalTrials.gov Ophthalmology , Clinical Trials
      Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.

      This study will compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane (I-ILM) flap vitreoretinal surgery for medium-to-large macular holes using infracyanine green (IFCG) vs brilliant blue G (BBG) dyeing. It is a single-center prospective, randomized study. One group of patients will undergo I-ILM vitrectomy with IFCG staining, the other vitrectomy with BBG staining. Postoperative six-month corrected distance visual acuity, macular hole closure rate, and SS-OCT parameters will be compared and statistically analyzed. The aim of the study is to verify if these parameters can be negatively affected by toxicity related to the use ...

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      Mentions: Azienda Ospedaliera San Paolo
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