[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640460":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":105,"collaborators":107,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":28,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":28,"enrollmentInfo":124,"targetDuration":28,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":59,"whyStopped":28,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Xiamen Ophthalmology Center Affiliated to Xiamen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Microincision Vitrectomy Surgery","EXPERIMENTAL","Participants undergo early microincision vitrectomy surgery (MIVS) using small-gauge instrumentation (25G or 27G) with high-speed vitreous removal. During surgery, scattered photocoagulation is applied to the far peripheral retina.",[13],"Procedure: Microincision Vitrectomy Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Panretinal Photocoagulation","ACTIVE_COMPARATOR","Participants receive standard panretinal photocoagulation (PRP) according to routine clinical practice. Treatment consists of approximately 1000 to 1500 laser burns delivered over one or two sessions within several weeks after randomization.",[19],"Procedure: Panretinal Photocoagulation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Panretinal photocoagulation delivered using standard laser therapy, consisting of approximately 1000 to 1500 laser burns applied over one or two sessions according to routine clinical practice.",[9],[15],{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":28},[15],null,[30],{"name":31,"affiliation":32,"role":33},"Xiaoxin Li, PhD","Xiamen Eye Center of Xiamen University","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"xiuju Chen, md","CONTACT","+8618060955810","joyychen@aliyun.com",{"name":41,"role":37,"phone":42,"phoneExt":28,"email":43},"wenjie huang","+8618150139807","xmykec@huaxiaeye.com",[45,58,73,82,91,96],{"facility":46,"status":47,"city":48,"state":49,"zip":28,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":28},"Peking University People's Hospital","COMPLETED","Beijing","Beijing Municipality","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},{"facility":32,"status":59,"city":60,"state":61,"zip":62,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"RECRUITING","Xiamen","Fujian","361000",{"type":53,"coordinates":64},[65,66],118.08187,24.47979,{"lat":66,"lon":65},[69,72],{"name":70,"role":37,"phone":71,"phoneExt":28,"email":39},"Xiuju Chen, MD","15121013344",{"name":31,"role":33,"phone":28,"phoneExt":28,"email":28},{"facility":74,"status":47,"city":75,"state":76,"zip":28,"country":50,"countryCode":51,"cosmosGeoPoint":77,"geoPoint":81,"contacts":28},"Henan Province People's Hospital","Zhengzhou","Henan",{"type":53,"coordinates":78},[79,80],113.64861,34.75778,{"lat":80,"lon":79},{"facility":83,"status":47,"city":84,"state":85,"zip":28,"country":50,"countryCode":51,"cosmosGeoPoint":86,"geoPoint":90,"contacts":28},"Jiangsu Provincial People's Hospital","Nanjing","Jiangsu",{"type":53,"coordinates":87},[88,89],118.77778,32.06167,{"lat":89,"lon":88},{"facility":92,"status":47,"city":84,"state":85,"zip":28,"country":50,"countryCode":51,"cosmosGeoPoint":93,"geoPoint":95,"contacts":28},"Nanjing Medical University affiliated Eye Hospital",{"type":53,"coordinates":94},[88,89],{"lat":89,"lon":88},{"facility":97,"status":47,"city":98,"state":99,"zip":28,"country":50,"countryCode":51,"cosmosGeoPoint":100,"geoPoint":104,"contacts":28},"The First Affiliated Hospital of Dalian Medical University","Dalian","Liaoning",{"type":53,"coordinates":101},[102,103],121.60222,38.91222,{"lat":103,"lon":102},{"type":106,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[108,109,110,112,114],{"name":83,"class":6},{"name":46,"class":6},{"name":111,"class":6},"Henan Provincial People's Hospital",{"name":113,"class":6},"Nanjing Medical University",{"name":97,"class":6},"100640460","early-vitrectomy-vs-prp-in-early-proliferative-diabetic-retinopathy-100640460",false,"NCT07586787","Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy","Comparison of Early Micro-invasive Vitrectomy Surgery Versus Panretinal Photocoagulation for the Treatment of Early Proliferative Diabetic Retinopathy: A Multi-center Randomized Trial","Inclusion Criteria:\n\n* Age 18 years or older.\n\nDiagnosis of type 2 diabetes mellitus.\n\nPresence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization.\n\nRelatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging.\n\nAbility and willingness to provide written informed consent.\n\nIf both eyes are eligible, the eye with worse vision will be included.\n\nExclusion Criteria:\n\n* Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye.\n\nRetinal traction or retinal detachment.\n\nOptic neuropathy.\n\nMacular edema caused by reasons other than diabetes.\n\nCoexisting ocular disease that may decrease visual acuity during the study.\n\nSubstantial cataract likely to decrease visual acuity by more than three lines.\n\nMajor ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months.\n\nYAG capsulotomy within the past 2 months.\n\nAny intravitreal injection within the past 3 months.\n\nAphakia.\n\nSevere external ocular infection.\n\nUncontrolled glaucoma.\n\nSignificant renal disease requiring dialysis or kidney transplantation.\n\nUnstable glycemic control.\n\nBlood pressure greater than 180\u002F110 mmHg.\n\nHistory of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requiring hospitalization within the past 4 months.\n\nPregnant, lactating, or intending to become pregnant during the study period.\n\nParticipation in another clinical trial.\n\nUnwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits.","ALL","18 Years",{"count":125,"type":126},100,"ESTIMATED","INTERVENTIONAL",[129],"NA","The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). It will also evaluate the safety and functional outcomes of early surgical intervention in this population.\n\nThe main questions it aims to answer are:\n\nDoes early MIVS increase the proportion of eyes achieving complete regression of retinal neovascularization at 12 months? Does early MIVS improve visual and functional outcomes, including visual acuity and visual field, compared to PRP? Researchers will compare early MIVS combined with peripheral scatter photocoagulation to standard PRP to determine whether early surgical intervention leads to better regression of neovascularization and improved clinical outcomes.\n\nParticipants will:\n\nReceive either MIVS with peripheral photocoagulation or standard PRP Undergo retinal imaging assessments including fundus fluorescein angiography (FFA) or optical coherence tomography angiography (OCTA) Complete follow-up visits over 12 months, including visual acuity testing, visual field testing, and optical coherence tomography (OCT) imaging Be monitored for the occurrence of vitreous hemorrhage and other clinical outcomes",[132],"Proliferative Diabetic Retinopathy (PDR)",[134,135,136,137],"Panretinal photocoagulation","Proliferative diabetic retinopathy","Retinal neovascularization","Vitrectomy","2026-05-07",{"date":140,"type":141},"2026-05-14","ACTUAL",{"date":143,"type":141},"2025-01-01",{"date":145,"type":126},"2026-06-10",{"name":5,"class":6},6]