[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"exophthalmos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:exophthalmos":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":41,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100643686","development-of-a-mobile-terminal-based-intelligent-detection-system-for-multiple-anterior-segment-diseases-of-the-eye-100643686",false,"NCT07634913","Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye","LENS","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Willing to participate and able to provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Unable to cooperate with anterior segment image capture (including smartphone-based photography or slit-lamp biomicroscopy).",true,"ALL","18 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","This is a multi-center, cross-sectional study evaluating a smartphone-based artificial intelligence (AI) system for anterior segment eye disease screening. The system is designed to identify 16 clinically important anterior segment conditions from images captured using a standard Android smartphone. A core design feature of the system is that all image analysis is performed entirely on the smartphone itself, without requiring internet connectivity or cloud-based server infrastructure.\n\nThe study is motivated by a structural challenge in the deployment of medical AI: systems that depend on cloud infrastructure for inference are non-functional in settings without reliable internet access, which disproportionately excludes populations in low-resource regions where the burden of preventable eye disease is highest. This study evaluates whether an on-device AI system, designed with operational constraints as a primary engineering objective, can deliver clinically acceptable diagnostic performance while remaining operable under real-world connectivity limitations.\n\nThe study comprises five evaluation components. First, the diagnostic performance of the AI system is benchmarked against board-certified ophthalmologists of varying seniority on a standardized set of smartphone-captured anterior segment images. Second, the usability of the system is evaluated among non-medical users who perform self-administered screening with minimal instruction, with per-screening time recorded across consecutive attempts to characterize the learning curve. Third, a head-to-head field trial directly compares the on-device AI system against a functionally equivalent cloud-based deployment of the same model architecture across key operational dimensions including screening duration, diagnostic performance, and user acceptability. Fourth, population-level screening is conducted among consecutively enrolled community residents at two low-resource sites, with per-disease sensitivity and specificity calculated against reference-standard slit-lamp examinations. Fifth, pre-specified health-economic and environmental analyses compare the two deployment modalities in terms of per-person screening cost, cost-effectiveness, per-inference electricity consumption, and projected carbon emissions at scale.\n\nThe reference standard for all diagnostic comparisons is slit-lamp biomicroscopic examination performed by board-certified ophthalmologists. The study is designed and reported in accordance with the DECIDE-AI reporting guideline for early-stage clinical evaluation of AI-driven decision-support systems.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Artifical Intelligence","Cataract","Pterygium","Keratopathy","Subconjunctival Hemorrhage","Conjunctivitis","Stye","Blepharitis","Entropion","Ectropion","Exophthalmos","Irregular Pupils","Conjunctival Concretions","Hyphema","Hypopyon","Corneal Transplant Status",[42,43,44,45],"Artificial Intelligence","Standalone Deployment","Smartphone","Eye Disease Screening","RECRUITING","2026-06-08",{"date":49,"type":50},"2026-06-09","ACTUAL",{"date":52,"type":50},"2023-12-12",{"date":54,"type":21},"2028-12",{"name":56,"class":57},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"100524715","phase-2-extension-study-of-two-doses-of-linsitinib-in-subjects-with-active-moderate-to-severe-thyroid-eye-disease-ted-100524715","NCT06112340","Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)","Inclusion Criteria:\n\n* Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\\\u003C 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301\n* Subject has not received any treatment for TED since Week 24 of VGN-TED-301\n* Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \\[FT4\\] and free triiodothyronine levels \\[FT3\\] \\\u003C50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial\n* Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study\n\nExclusion Criteria:\n\n* The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.",{"count":67,"type":21},75,"INTERVENTIONAL",[70,71],"PHASE2","PHASE3","The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.",[74,75,76,77,78,79,80,81,82,83,35,84],"Thyroid Eye Disease","Graves Orbitopathy","Endocrine System Diseases","Eye Diseases","Thyroid Associated Ophthalmopathy","Graves Ophthalmopathy","Thyroid Diseases","Orbital Diseases","Proptosis","IGF1R","Hashimoto","2025-02-24",{"date":87,"type":50},"2025-02-25",{"date":89,"type":50},"2023-10-11",{"date":91,"type":21},"2026-06",{"name":93,"class":94},"Sling Therapeutics, Inc.","INDUSTRY"]