[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594843":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":54,"collaborators":56,"id":60,"slug":20,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Imaging during ophthalmic surgery","EXPERIMENTAL","Research 4D MIOCT imaging will be performed in the operating room during clinically-indicated surgical procedures. Imaging will be of one or both eyes.",[13],"Device: 4D MIOCT integrated into a Zeiss Artevo 800",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","4D MIOCT integrated into a Zeiss Artevo 800","4D MIOCT integrated into a Zeiss Artevo 800 surgical microscope with an add-on investigational 3D OCT scanner",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Cynthia A Toth, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","919-684-0544","cynthia.toth@duke.edu",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},"Michelle N McCall, MCAPM, BA","michelle.mccall@duke.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Duke University Eye Center","RECRUITING","Durham","North Carolina","27710","United States",{"type":42,"coordinates":43},"Point",[44,45],-78.89862,35.99403,{"lat":45,"lon":44},[48,49,53],{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},{"name":50,"role":27,"phone":51,"phoneExt":20,"email":52},"Neeru Sarin, MD","919-668-5641","neeru.sarin@duke.edu",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":59},"Carl Zeiss Meditec AG","INDUSTRY","100594843",false,"NCT07024719","4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800","First Use of Duke 4D Microscope Integrated OCT (MIOCT) Integrated Into Zeiss Artevo 800 Ophthalmic Surgical Microscope in the Operating Room","4D MIOCT","Inclusion Criteria:\n\n* Adult participants 18 years of age and older\n* Patients undergoing surgery for ocular disease\n* Adults able and willing to give informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with any ocular disease that restricts the ability to perform OCT scanning","ALL","18 Years",{"count":70,"type":71},5,"ESTIMATED","INTERVENTIONAL",[74],"NA","The study team will conduct the first in-human pilot studies using 4D MIOCT for imaging in the operating room. Building on the earlier integration and wet-lab validations, the researchers will assess the system's ease of use, safety, and visualization of intended structures during various anterior and posterior segment ophthalmic procedures.",[77,78,79],"Corneal Diseases","Retinal Diseases","Ocular Diseases",[81,82,83],"Microscope integrated OCT","intraoperative OCT","optical coherence tomography (OCT)","2026-01-14",{"date":86,"type":87},"2026-01-16","ACTUAL",{"date":89,"type":87},"2025-07-24",{"date":91,"type":71},"2026-10",{"name":5,"class":6},1]