Clinical Research Directory

Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice

Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions. This retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.

Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions

Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.

Natural History Study of Inherited Retinal Diseases

This prospective, observational investigation seeks to delineate the interplay between chromatic vision deficits and both functional visual outcomes and anatomical retinal biomarkers in individuals affected by Inherited Retinal Dystrophies (IRDs). The study will recruit approximately 200 subjects, encompassing a heterogeneous population of IRD patients-spanning a range of genotypes and clinical severities-as well as control participants devoid of retinal pathology. All enrolled individuals will undergo a standardized battery of evaluations, including quantitative color vision assessment, best-corrected visual acuity (BCVA) determination, and advanced multimodal retinal imaging. The principal aim is to characterize the relationship between impairments in color discrimination and morphologic disruptions within the outer retinal layers, with particular emphasis on the continuity and reflectivity of the ellipsoid zone (EZ)-historically referred to as the inner segment/outer segment (IS/OS) junction-assessed through spectral-domain optical coherence tomography (SD-OCT). Further, the study will explore associations between chromatic perceptual deficits and underlying genetic mutations, mutation patterns specific to IRD subtypes, and the influence of patient age on the severity and progression of color vision loss. A key secondary objective is the clinical appraisal and validation of a novel diagnostic modality, the Moji Low-Vision Color Discrimination Test (Moji Test), which is specifically engineered to quantify residual color perception in individuals with advanced central visual impairment. The test's discriminatory capacity will be benchmarked against established color vision testing paradigms to assess its reliability, clinical sensitivity, and suitability for implementation in populations with severe visual acuity reduction. By incorporating a genetically and phenotypically diverse IRD cohort, the study is designed to enable granular, stratified analyses that will refine the understanding of structural-functional correlations in hereditary retinal disease. The inclusion of a control group with preserved retinal architecture and normal color vision function will provide essential normative baselines for comparative evaluation and statistical inference.

Endovascular Treatment of Cerebrovascular Diseases Guided by Optical Coherence Tomography (OCT) Technology（CVD-OCT）

OCT techniques have been used in the assessment of both intracranial and extracranial lesions.(1) Preprocedural evaluation: The morphologic characteristics of carotid atherosclerotic plaques can be evaluated by OCT before surgery to identify vulnerable plaques and guide interventional therapy. It has been shown that plaque image features observed by OCT and based on the "thin fibrous cap" characteristics of plaques can predict rupture and thrombotic risk of atherosclerotic plaques. Similarly, the results of studies based on OCT plaque features suggest that OCT plaque features can be used for the identification of symptomatic carotid plaques.The results of studies based on OCT plaque characteristics suggest that OCT plaque characteristics correlate with the degree of carotid stenosis and ischemic symptoms. Therefore, it is important to use OCT to assess plaque characteristics prior to cerebrovascular interventions and to identify high-risk plaques that are prone to cause ischemic events, in order to guide carotid interventions, especially for patients whose stenosis has not reached the level of intervention, but who have not yet reached the level of ischemic events, or who are at risk of ischemic events.lesions with stenosis not reaching the level of intervention but with the presence of vulnerable plaques are of great significance.(2) Evaluation of immediate post-interventional outcomes: Currently, OCT has been used to evaluate the expansion rate of the relevant stent immediately after stenting, stent adherence, protrusion of diseased tissue into the lumen of the vessel, and in-stent thrombosis.In addition, in acute occlusion recanalization of intracranial vessels, the application of OCT can identify the nature of lesions during treatment, such as clips, atherosclerotic stenosis, and other lesions, and guide the development of surgical strategies. (3) Interventional follow-up: OCT can be used in post-interventional follow-up for post-stenting endothelial repair, in-stent restenosis, de novo atherosclerosis, and thrombus formation. In summary, OCT can accurately assess the nature of cerebrovascular lesions and plaques and guide clinical interventions.For medical centers that have the conditions, it is recommended to standardize the application of OCT to guide the interventional precision treatment of ischemic cerebrovascular disease.In the future, a clinical study database of OCT in Chinese patients with ischemic cerebrovascular disease should be established to provide evidence-based medical evidence of OCT in the diagnosis and treatment

Optical Coherence Tomography in Retinal Vein Occlusion

This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.

Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.

Insulin-like growth factor 1 (IGF-1) is the primary peripheral mediator of growth hormone (GH) and has pleiotropic effects on development, differentiation, metabolism, and cell survival. Several in vivo and in vitro studies suggest that IGF-1 may have a protective effect on atherosclerosis as it suppresses macrophage recruitment and activation, cytokine production, and extracellular matrix degradation while promoting smooth muscle cell migration and proliferation and extracellular matrix deposition. The protein sKlotho appears to be closely related to the GH-IGF-1 axis, and some animal and in vitro studies hypothesize its protective role in the cardiovascular system. The GH-IGF-1 axis and sKlotho influence mechanisms determining coronary atherosclerosis. Circulating levels of IGF-1 and sKlotho may correlate with the morphology of atherosclerotic plaques and particularly with the vulnerability of coronary lesions. Objectives: To evaluate the correlation between atherosclerotic plaque phenotype and the GH-IGF-1 axis and sKlotho in patients with chronic coronary syndrome using intravascular imaging with Optical Coherence Tomography (OCT). Methods:All patients with chronic coronary syndrome who meet the inclusion and exclusion criteria and undergo coronary angiography and intravascular imaging with optical coherence tomography will be included. At the end of the procedure, a blood sample will be taken to measure IGF-1, sKlotho, and GH receptor (GHR) polymorphism.