[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-retinopathy-dr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-retinopathy-dr":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,67,98,124,152,179,208,228,252,273,296,328,358,378,402,424,439,475,499,520,540,564],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643679","phase-4-to-evaluate-the-efficacy-and-safety-of-n-acetyl-cysteine-administration-in-patients-with-diabetic-retinopathy-100643679",false,"NCT07634991","To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy","Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy","Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus\n\n  * Patients with mild to moderate degrees of diabetic retinopathy\n  * Patients over the age of 18 and under the age of 70 years\n  * Patients who voluntarily give their informed consent\n  * HbA1C (glycosylated hemoglobin) less than 10%\n  * FBG less than 240 mg\u002Fdl\n  * Body mass index (BMI) less than 40 kg\u002Fm2\n\nExclusion Criteria:\n\n* • Patients with any other ophthalmologic conditions than diabetic retinopathy\n\n  * Patients with previous surgical or laser treatment\n  * Pregnant or breastfeeding patients\n  * Patients using antioxidants.\n  * Systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization\n  * Patients who are currently participating in other clinical trials\n  * Severe liver or renal disease, (AST or ALT \\>3 times ULN or Total bilirubin \\>3 times ULN), (CrCl\\\u003C 60 ml\u002Fmin)\n  * Current history of drug or alcohol abuse Malignancies","ALL","18 Years","70 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","N-acetylcysteine (NAC) emerges as a crucial factor in mitigating oxidative stress and inhibiting vascular endothelial activation in diabetic patients, through its effect on VEGF expression as VEGF is involved in the development of diabetic microvascular complications through the promotion of retinal angiogenesis and increased vascular permeability.\n\nIt was reported in the literature that NAC administration was safe in several studies. It was shown that the dose of 1200 mg is safe and effective.\n\nTo the best of our knowledge, the present study is the first to be designed to evaluate the effect of N-acetyl cysteine on diabetic retinopathy in type 2 diabetic patients.",[27],"Diabetic Retinopathy (DR)","RECRUITING","2026-06-03",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":32},"2026-01-10",{"date":36,"type":21},"2026-12-30",{"name":38,"class":39},"Ain Shams University","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100631411","proteomic-biomarker-identification-in-age-related-macular-degeneration-diabetic-retinopathy-and-retinal-detachment-100631411","NCT07500324","Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment","Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches","PRO Project","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to understand the study procedures and provide written informed consent\n* Willingness and ability to comply with study procedures and visits\n\nFor case subjects:\n\n* Patients with age-related macular degeneration (intermediate or advanced, including geographic atrophy or neovascular AMD)\n* Patients with diabetic retinopathy (non-proliferative or proliferative, with or without diabetic macular edema)\n* Patients undergoing surgery for primary or recurrent retinal detachment\n\nFor control subjects:\n\n* Patients scheduled for cataract surgery with no documented retinal diseases (e.g., AMD, diabetic retinopathy, retinal vascular occlusions, or retinal epithelial disorders)\n* Outpatients with no documented retinal diseases\n* For retinal detachment subgroup: patients undergoing macular surgery (e.g., macular pucker or macular hole) or cataract surgery with attached retina\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Presence of infectious ocular diseases\n* Alterations in the electrophoretic profile of gamma globulins",{"count":50,"type":21},260,[52],"NA","This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration, diabetic retinopathy (DR), and retinal detachment (RD). A total of approximately 260 participants (cases and controls) will be enrolled at a single center.\n\nBiological samples, including peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, will be collected during routine clinical and surgical procedures. Advanced clinical proteomics approaches will be applied to characterize molecular signatures associated with disease onset, progression, and response to treatment.\n\nThe study seeks to improve the understanding of disease pathophysiology and support the development of novel diagnostic and prognostic biomarkers in ophthalmology.",[55,27,56],"Age-Related Macular Degeneration (AMD)","Retinal Detachment","2026-05-29",{"date":59,"type":32},"2026-06-02",{"date":61,"type":32},"2024-01-24",{"date":63,"type":21},"2027-01",{"name":65,"class":39},"Fondazione G.B. Bietti, IRCCS",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100615388","retinal-clinical-assessment-with-ai-derived-quantitative-information-100615388","NCT07291960","Retinal Clinical Assessment With AI-derived Quantitative Information","AI-derived Retinal Quantification Versus Routine Clinical Interpretation in Ophthalmic Assessment: a Randomized Controlled Trial","Inclusion Criteria:\n\nClinician Participants (Report Writers)\n\n1. Board-certified ophthalmologists or ophthalmology trainees (registrars or fellows) with clinical experience in interpreting fundus images.\n2. Capable of independently completing retinal clinical reports based on fundus photography.\n3. Willing and able to participate in the study tasks (report writing) under assigned study conditions.\n4. Able to provide informed consent.\n\nExpert Evaluators (Outcome Assessors)\n\n1. Senior ophthalmologists with at least 5 years of post-certification clinical experience.\n2. Not involved in the report-writing stage of the study.\n3. Willing to evaluate de-identified reports across predefined quality dimensions.\n4. Able to provide informed consent.\n\nFundus Images (Data Inputs)\n\n1. Retinal fundus photographs of sufficient quality for clinical interpretation.\n2. Images representing a range of common retinal findings (normal or abnormal).\n3. Previously collected, de-identified images with no patient-identifiable information.\n\nExclusion Criteria:\n\nClinician Participants\n\n1. Lack of experience in interpreting fundus images (e.g., interns, medical students).\n2. Prior involvement in the development, training, or validation of the AI system being tested.\n3. Inability to complete reporting tasks due to time constraints or technical limitations.\n4. Any condition that may interfere with ability to perform study tasks (e.g., prolonged absence).\n\nExpert Evaluators\n\n1. Participation in the intervention or control reporting arms.\n2. Prior exposure to or involvement in development of the AI system.\n3. Any conflict of interest affecting impartiality of report quality evaluation.\n\nFundus Images\n\n1. Poor-quality images with insufficient clarity for interpretation.\n2. Images containing artifacts or cropping that prevent accurate segmentation or assessment.\n3. Images with any remaining patient identifiers (excluded to maintain confidentiality).",true,{"count":76,"type":21},29,"21 Days","OBSERVATIONAL","This randomized controlled trial evaluates whether providing clinicians with AI-derived quantitative retinal information improves the quality and efficiency of retinal clinical assessment. Participating ophthalmologists and ophthalmology trainees will be randomly assigned to one of two groups. The intervention group will write clinical reports with access to automated quantitative measurements generated from fundus image analysis, including multiple retinal structural and vascular biomarkers. The control group will complete the same reporting tasks using only the original fundus images without AI-generated quantitative information.\n\nAll reports produced by both groups will be de-identified and independently evaluated by a separate panel of senior ophthalmologists who are blinded to group allocation. The expert evaluators will assess report accuracy, completeness, clarity, and overall clinical quality using predefined scoring criteria. The study aims to determine whether access to quantitative retinal biomarkers enhances clinicians' reporting performance and reduces reporting time during retinal assessment tasks.",[81,27,82,83,84,85,86,87],"no Obvious Abnormalities","AMD","Cup-to-disc Ratio Bigger Than 0.5","Pathological Myopia","Macular Hole","Epiretinal Membrane","Retinal Vein Occlusion (RVO)","NOT_YET_RECRUITING","2026-04-28",{"date":91,"type":32},"2026-04-29",{"date":93,"type":21},"2026-04-15",{"date":95,"type":21},"2026-05-15",{"name":97,"class":39},"Beijing Tongren Hospital",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":66},"100622079","clinical-efficacy-of-implementing-an-ai-samd-for-funduscopy-analysis-in-patients-with-diabetes-mellitus-100622079","NCT07378956","Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus","Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol","SAFE-DM","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* A documented diagnosis of type 2 diabetes mellitus.\n* Ability to communicate adequately and provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* A prior diagnosis of diabetic retinopathy at the time of screening.\n* A history of ophthalmic surgery within 6 months prior to the screening date.\n* A diagnosis of type 1 diabetes mellitus.\n* Pregnancy at the time of screening.\n* Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.","19 Years",{"count":108,"type":21},340,[52],"The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.",[27,112,113],"Diabete Mellitus","Fundus Photography","2026-04-08",{"date":116,"type":32},"2026-04-13",{"date":118,"type":32},"2026-04-07",{"date":120,"type":21},"2027-08-31",{"name":122,"class":123},"VUNO Inc.","INDUSTRY",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":66},"100632901","video-intervention-to-improve-understanding-of-diabetic-retinopathy-at-zuckerberg-san-francisco-general-hospital-and-trauma-center-100632901","NCT07519707","Video Intervention to Improve Understanding of Diabetic Retinopathy at Zuckerberg San Francisco General Hospital and Trauma Center","Addressing Low Patient Follow-up Rates Among Patients With Diabetes in the Eye Clinic at Zuckerberg San Francisco General Hospital and Trauma Center","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus with or without diabetic retinopathy\n* Scheduled visit to ZSFG clinic is specifically for diabetes mellitus or diabetic retinopathy care\n* Able to speak and understand English or Spanish\n\nExclusion Criteria:\n\n* Unable to view or understand the videos due to significant vision obstruction or impairment",{"count":132,"type":21},150,[52],"The study will evaluate whether videos can improve understanding of diabetic eye disease, and follow-up rates in the eye clinic.",[27,136],"Macular Edema (ME)",[138,139,140,141,142],"diabetic retinopathy","diabetes","ophthalmology","vision","health literacy","2026-04-06",{"date":145,"type":32},"2026-04-09",{"date":147,"type":21},"2026-05",{"date":149,"type":21},"2027-12",{"name":151,"class":39},"University of California, San Francisco",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":66},"100632927","biomarkers-in-diabetic-retinopathy-treated-with-faricimab-vs-biosimilar-ranibizumab-100632927","NCT07520045","Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab","A Comparative Analysis of OCT and OCT Angiography Biomarkers and Systemic Laboratory Parameters in Patients With Diabetic Retinopathy Undergoing Treatment With Faricimab or Biosimilar Ranibizumab Following Three Loading Doses","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diabetic retinopathy with or without central macular edema\n* Indication for intravitreal anti-VEGF therapy according to current clinical guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment\n* Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment\n* Retinal laser photocoagulation in the study eye within 3 months prior to enrollment\n* Presence of other ocular, retinal or macular diseases that may affect OCT\u002FOCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)\n* Retinal detachment, preretinal fibrosis, vitreomacular traction\n* Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT\u002FOCTA imaging\n* Uncontrolled glaucoma (intraocular pressure \\> 30 mmHg in study eye)\n* Active ocular inflammation\n* Suspected active ocular infection in either eye\n* Any febrile illness within 1 week prior to first injection\n* History or presence of any clinically significant disease, non-diabetic metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the opinion of the investigator, may contraindicate treatment with faricimab or biosimilar ranibizumab, interfere with the interpretation of study results, or place the participant at increased risk of treatment-related complications.\n* Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks\n* Known hypersensitivity to faricimab or biosimilar ranibizumab or any of its excipients\n* Participation in another clinical trial that may affect study outcomes\n* Inability to comply with study procedures or follow-up",{"count":160,"type":21},100,[52],"The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are:\n\nWhich OCT and OCT angiography biomarkers predict early treatment response? How do imaging biomarkers change after three loading doses of treatment? Are imaging biomarkers associated with systemic laboratory parameters? Researchers will compare faricimab to biosimilar ranibizumab to see if there are differences in imaging biomarkers and early treatment response.\n\nParticipants will:\n\n* be randomized in a 1:1 ratio using a computer-generated randomization sequence\n* undergo comprehensive ophthalmic examinations, including visual acuity and intraocular pressure measurement\n* undergo OCT and OCT angiography imaging at each visit\n* receive three intravitreal injections during the loading phase\n* attend follow-up visits from baseline to 4-5 weeks after the third injection\n* provide blood samples for systemic laboratory analysis",[27,164],"Diabetic Macular Edema (DME)",[166,167,168,169,170],"Diabetic Retinopathy","ranibizumab","faricimab","biomarkers","OCT","2026-04-02",{"date":145,"type":32},{"date":174,"type":32},"2026-03-12",{"date":176,"type":21},"2027-06-01",{"name":178,"class":39},"Osijek University Hospital",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":74,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":189,"conditions":190,"keywords":195,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":40},"100631218","artificial-intelligence-assisted-diagnosis-in-ophthalmology-100631218","NCT07497815","Artificial Intelligence-assisted Diagnosis in Ophthalmology","Development and Validation of an Artificial Intelligence-assisted Diagnostic System for Ophthalmic Pathologies","AI-OPHTH-CR","Inclusion Criteria:\n\n* Image corresponds to patient ≥18 years of age at time of capture\n* Image modality is one of: fundus photography, posterior segment OCT, anterior segment photography, automated perimetry, or video-OCT\n* Image quality sufficient for diagnostic interpretation (adequate resolution, focus, illumination, complete visualization of anatomical area of interest, no major artifacts)\n* Minimum clinical data available (age or age group, sex, and diagnosis or clinical indication)\n* Image captured during routine clinical care (not specifically for research)\n* No patient objection to use of medical data for research (when applicable per center policy)\n\nExclusion Criteria:\n\nCLINICAL:\n\n* Images from eyes with recent intraocular surgery (\\\u003C3 months)\n* Images from eyes with severe ocular trauma distorting anatomy\n* Images from patients with rare or unique ocular pathologies not allowing generalization\n* Images post-recent laser treatment where acute changes may confuse analysis\n\nTECHNICAL:\n\n* Severely degraded image quality (extreme blur, severe under\u002Foverexposure, major artifacts preventing interpretation)\n* Duplicate images of same eye on same date\n* Images with missing or clearly erroneous metadata\n* Images in non-standard or corrupted formats that cannot be processed\n\nSex\u002FGender: All Minimum Age: 18 Years Maximum Age: No limit Accepts Healthy Volunteers: Yes (images of healthy eyes without pathology are included as controls)",{"count":188,"type":21},15000,"This is a retrospective, multicenter, observational study designed to develop and validate an artificial intelligence (AI) system capable of detecting and classifying major ophthalmic diseases (glaucoma, cataract, diabetic retinopathy, and other retinal pathologies) in the Costa Rican population. The study will use approximately 15,000 existing medical images from digital archives of two ophthalmic centers in Costa Rica, without active participant recruitment or capture of new images.\n\nThe primary motivation is that AI systems developed in other countries (primarily Asian, European, or North American populations) do not necessarily perform with the same accuracy when applied to Latin American populations. This study seeks to establish a precedent for the importance of locally validating any medical AI technology before clinical implementation.",[191,27,192,193,194],"Macular Degeneration","Glaucoma","Keratoconus","Cataract",[196,140,197,198],"artificial inteligence","imaging","bias","2026-03-26",{"date":201,"type":32},"2026-04-01",{"date":203,"type":21},"2026-05-01",{"date":205,"type":21},"2029-05-01",{"name":207,"class":123},"Marisse Masis-Solano",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":66},"100628931","diabetic-retinopathy-prevalence-and-risk-factors-100628931","NCT07468058","Diabetic Retinopathy Prevalence And Risk Factors","Diabetic Retinopathy Prevalence And Risk Factors From A Hospital - Based Cohort In Central Vietnam","DR-CENTRAL","Inclusion Criteria:\n\n* Diagnosed diabetes mellitus (type 1 or type 2) according to ADA criteria\n* Underwent ophthalmic examination including dilated fundus examination and OCT\n* Available electronic medical records with key clinical and laboratory data\n\nExclusion Criteria:\n\n* Gestational diabetes mellitus\n* Media opacity precluding fundus examination (advanced cataract, corneal opacity, dense vitreous hemorrhage)\n* Other retinal diseases (e.g., hypertensive retinopathy, retinal vein occlusion)\n* History of ocular trauma or intraocular surgery within 6 months",{"count":217,"type":21},300,"The goal of this retrospective observational study is to evaluate the prevalence and severity of diabetic retinopathy (DR) and to identify associated risk factors among patients with diabetes mellitus at Gia Dinh Family Hospital in Da Nang, Vietnam.\n\nThe main questions it aims to answer are:\n\n1. What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?\n2. Which clinical and laboratory factors are associated with the presence of diabetic retinopathy?",[27],"2026-03-10",{"date":174,"type":32},{"date":223,"type":32},"2025-11-25",{"date":225,"type":21},"2026-03-30",{"name":227,"class":39},"Da Nang Family General Hospital",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":250,"locationsCount":66},"100615772","using-implementation-science-to-adapt-a-targeted-transportation-intervention-for-patients-with-diabetic-retinopathy-pronto-eye-100615772","NCT07296952","Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (PRONTO-EYE)","PRONTO-EYE","Inclusion Criteria:\n\n* Established patient\n* Medicaid insurance\n* History of diabetic retinopathy\n* Lives within 25 miles of the clinic\n* English speaking",{"count":236,"type":21},60,[52],"This is a a type 3 hybrid effectiveness-implementation pilot study to evaluate the PRONTO-EYE intervention, a rideshare transportation program, in patients with diabetic retinopathy with Medicaid insurance on adherence to ophthalmology visits.",[27],[241,242,243],"diabetic retinopathy (DR)","transportation","Medicaid","2026-02-25",{"date":246,"type":32},"2026-02-27",{"date":248,"type":32},"2026-02-03",{"date":176,"type":21},{"name":251,"class":39},"University of Illinois at Chicago",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":4},"100624055","preliminary-assessment-of-an-automated-tool-for-diabetic-retinopathy-screening-100624055","NCT07404657","Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening","Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening","Inclusion Criteria:\n\n* 22 years old or older\n* diabetes or diabetic retinopathy\n* understand the study information and able to sign a consent form\n\nExclusion Criteria:\n\n* cannot tolerate eye imaging tests\n* laser treatment or injections\n* eye surgery, except for simple cataract surgery\n* currently involved in another study\n* pregnant\n* cannot or do not want to have your eyes dilated\n* photodynamic therapy within the last 90 days","22 Years",{"count":261,"type":21},198,"This study is being done to evaluate the performance of a software that uses artificial intelligence to analyze photographs of the retina to help detect diabetic retinopathy. The study will also assess the safety of the software in combination with a fundus camera already available on the market. This software analyzes retinal photographs to detect more than mild diabetic retinopathy in adults with diabetes. The results will be compared to expert human evaluations.",[27],"2026-02-05",{"date":266,"type":32},"2026-02-11",{"date":268,"type":21},"2026-02",{"date":270,"type":21},"2026-04",{"name":272,"class":123},"Centervue SpA",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":279,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":66},"100619989","impact-of-the-new-generation-anti-diabetic-drugs-on-diabetic-retinopathy-100619989","NCT07351786","Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy","Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes for \\>5 years\n* Using Diabetes medications (metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors) for a period of 2-3 years\n\nExclusion Criteria:\n\n* Gestational Diabetes\n* Type 1 Diabetes\n* Severe non-proliferative diabetic retinopathy (NPDR) at baseline\n* Proliferative diabetic retinopathy (PDR) at baseline\n* Pregnant and breastfeeding women","25 Years",{"count":281,"type":21},70,"This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including metformin) only. Early intervention is critical, as treatment options for advanced stages of DR are limited in terms of their ability to restore impaired vision and their high associated costs. By focusing on delaying the occurrence of diabetic retinopathy, the investigators aim to reduce the burden of DR and improve the quality of life for diabetic patients.",[284,285,27,286],"Diabetes (DM)","Retinopathy, Diabetic","Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus","2026-01-12",{"date":289,"type":32},"2026-01-20",{"date":291,"type":32},"2025-08-01",{"date":293,"type":21},"2026-09",{"name":295,"class":39},"Sara A Belal",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":303,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":40},"100616143","phase-4-comparing-single-versus-multiple-anti-vegf-injections-in-diabetic-patients-undergoing-cataract-surgery-100616143","NCT07301775","Comparing Single Versus Multiple Anti-VEGF Injections in Diabetic Patients Undergoing Cataract Surgery","A Randomised Controlled Trial Comparing Efficacy of Single Versus Multiple Intravitreal Anti-VEGF Injections to Prevent Diabetic Retinopathy Progression in Patients Undergoing Cataract Surgery","Inclusion Criteria:\n\n* diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract\n\nExclusion Criteria:\n\n* presence of proliferative diabetic retinopathy (PDR), diabetic macular oedema involving foveal centre, history of intraocular surgery or laser photocoagulation or prior anti-VEGF injection therapy in the study eye within past six months, history of intraocular inflammation (uveitis), glaucoma, mature cataract preventing satisfactory fundus examination preoperatively, poor glycaemic control (HbA1c\\>9%), pregnant and lactating women, known allergy to aflibercept (anti-VEGF used) and systemic thromboembolic events (stroke, myocardial infarction) within the last three months.","40 Years",{"count":305,"type":21},166,[24],"Objective of this randomised controlled trial is to compare the efficacy of a single per operative anti VEGF injection with repeated postoperative anti VEGF injections in the prevention of diabetic retinopathy progression after cataract surgery.\n\nThis Randomised Controlled Trial (RCT) will be conducted at Sahiwal Teaching Hospital and University College of Medicine \\& Dentistry Lahore. Duration of study will be from January 2026 to September 2026. This study will be single blind and parallel group research.\n\nThe study will include diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract.\n\nExclusion criteria include proliferative diabetic retinopathy, center-involving diabetic macular oedema (DME), poor glycemic control (HbA1c \\>9%), glaucoma, uveitis, prior ocular surgery or laser, and recent systemic thromboembolic events.\n\nSubjects will be randomly divided into two groups, each containing 83 subjects. Standard phacoemulsification with intraocular lens implantation will be performed in all participants.\n\nA single intra vitreal Aflibercept injection ( 2mg\u002F0.05 ml ), will be given to group 1 participants. While, group 2 participants will receive an intra operative injection plus two additional injections at 1 month and 2 months postoperatively.\n\nFor all participants, follow up will be performed at 1 week, 1 month, 2 month, 3 month and 6 month.\n\nPrimary Outcome include progression of diabetic retinopathy (DR) severity (≥1 stage according to the guidelines of the international clinical diabetic retinopathy disease severity scale ICDR) or onset\u002Fprogression of DME.\n\nSecondary Outcomes include changes in best corrected visual acuity, changes in central macular thickness (CMT), and need for rescue treatment.\n\nSPSS version 26 will be utilised to analyse the data. P ≤ 0.05 will be taken as statistically significant. Qualitative variable like diabetic retinopathy grading and diabetic macular oedema status will be analysed by utilising Pearson's chi-square test. Quantitative variables like central macular thickness will be analysed by employing t-test.",[27,164,194,309,310],"Phacoemulfisication+IOL Implantation","Intravitreal Injection",[312,313,314,310,315,316,317,318],"Vascular endothelial growth factor","Aflibercept","Cataract Extraction","Phacoemulsification","Diabetic retinopathy","Diabetic macular edema","Intraocular lens implantation","2025-12-10",{"date":321,"type":32},"2025-12-24",{"date":323,"type":21},"2026-01-01",{"date":325,"type":21},"2026-09-30",{"name":327,"class":39},"Ahmad Zeeshan Jamil",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":74,"sex":16,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":40},"100610031","assessment-of-ai-program-dristi-as-a-screening-tool-100610031","NCT07222293","Assessment of AI Program 'DRISTi' as a Screening Tool","Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations","Inclusion Criteria:\n\n1. Ability to sign and date the informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age (≥)21 years of age or older\n4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)\n\n   1. Hemoglobin A1c (HbA1c) ≥ 6.5%\n   2. Fasting Plasma Glucose (FPG) ≥ 126 mg\u002FdL (7.0 mmol\u002FL)\n   3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg\u002FdL (11.1 mmol\u002FL)\n\nExclusion Criteria:\n\n1. Persistent visual impairment in one or both eyes;\n2. History of macular edema or retinal vascular (vein or artery) occlusion;\n3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;\n4. Subject is contraindicated for fundus photography (for example, has light sensitivity);\n5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;\n6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or\n7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs\n8. Subject falls into one of the below categories:\n\n   * Adults unable to consent (individuals w\u002F impaired decision-making capacity)\n   * Individuals who are not yet adults (infants, children, teenagers)\n   * Pregnant women\n   * Prisoners","21 Years",{"count":337,"type":21},900,"A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion\u002Fexclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.",[27],[341,342,343,166,344,345,346,347,348],"Artificial Intelligence","Ophthalmic Device","AI","Diabetes","DR","Screening","Online\u002FOffline","Fundus Camera","2025-12-05",{"date":351,"type":32},"2025-12-09",{"date":353,"type":32},"2025-11-23",{"date":355,"type":21},"2026-03",{"name":357,"class":123},"Artelus AI",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":4},"100612109","high-throughput-large-model-based-ai-assisted-diagnosis-using-oct-100612109","NCT07249307","High-throughput Large-model-based AI-assisted Diagnosis Using OCT","Study on Key Technologies for High-throughput Large-model-based AI-assisted Diagnosis Using OCT","Inclusion Criteria:\n\n* 1\\. Patients of any age or sex who undergo OCT and\u002For OCT angiography (OCTA) examinations as part of routine clinical care at Peking Union Medical College Hospital.\n\n  2\\. Clinical diagnosis of at least one of the following conditions: Diabetic retinopathy, Branch retinal vein occlusion, Central retinal vein occlusion, Age-related macular degeneration, Pathologic myopia with choroidal neovascularization and Glaucoma with optic nerve damage.\n\n  3\\. Imaging quality sufficient for analysis based on predefined OCT\u002FOCTA quality control criteria.\n\n  4\\. Ability to provide informed consent (for prospective participants), or availability of medical records that meet institutional ethical requirements (for retrospective data).\n\nExclusion Criteria:\n\n\\- 1. Poor-quality OCT\u002FOCTA images that do not meet analysis standards (e.g., severe motion artifacts, media opacity, incomplete scans).\n\n2\\. Patients unable to cooperate with standard ophthalmic imaging procedures. 3. Any condition judged by investigators to preclude accurate imaging evaluation or reliable diagnostic interpretation.",{"count":366,"type":21},2000,"This observational study aims to establish key technologies for high-throughput, large-model-based AI-assisted diagnosis using optical coherence tomography (OCT) and OCT angiography (OCTA). The study will collect real-world OCT\u002FOCTA images and corresponding clinical information from patients with common blinding retinal and optic nerve diseases at Peking Union Medical College Hospital.\n\nA high-throughput diagnostic framework based on large-scale artificial intelligence models will be developed and evaluated. The primary objective is to determine the diagnostic performance of the AI system, including its ability to identify diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, and glaucoma-related optic nerve damage.\n\nThe results of this study are expected to support the development of standardized, efficient, and scalable AI-assisted diagnostic pathways for OCT imaging in clinical practice.",[27,87,55,369,192],"Pathologic Myopia","2025-11-18",{"date":223,"type":32},{"date":373,"type":21},"2025-11-30",{"date":375,"type":21},"2028-12-31",{"name":377,"class":39},"Peking Union Medical College Hospital",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":66},"100598296","artificial-intelligence-aided-screening-for-patients-with-diabetic-retinopathy-and-age-related-macular-degeneration-in-family-medicine-and-geriatric-medicine-outpatient-clinics-100598296","NCT07069647","Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics","Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above.\n* VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above.\n\nExclusion Criteria:\n\n* The patient does not agree to participate in the trial or is unable to provide informed consent.","20 Years",{"count":387,"type":21},4300,[52],"Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient\u002Fphysician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.",[55,27],[55,27,341,392,113],"Randomized Controlled Trial","2025-11-16",{"date":395,"type":32},"2025-11-19",{"date":397,"type":32},"2025-10-02",{"date":399,"type":21},"2027-12-31",{"name":401,"class":39},"National Taiwan University Hospital",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":40},"100590532","improving-patient-centered-care-for-diabetes-in-bangladesh-through-dynamic-integration-of-vision-care-on-the-supply-side-100590532","NCT06968637","Improving Patient-centered Care for Diabetes in Bangladesh Through \"Dynamic Integration\" of Vision Care on the Supply Side","Inclusion Criteria:\n\n* Diagnosed with DM\n* Diagnosed with DR in at least one eye\n* Over 30 years of age\n* Currently treated at the Dinajpur Diabetes Hospital and Gausul Azam BNSB Eye Hospital in Bangladesh\n* willingness to participate in the study\n\nExclusion Criteria:\n\n* Any ocular condition impairing the view of the fundus sufficiently to preclude grading of the image for DR.\n* Inability to comply with retinal photography to the extent that a gradable image cannot be captured, or any other factor leading to absence of sufficient images to grade at least one eye of a participant.\n* Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)\n* Unwilling to participate in the study, or incapable of giving informed consent.","30 Years",{"count":410,"type":21},336,[52],"The goal of this clinical trial is to determine whether integration of vision care into the DM treatment system, by providing specific recommendations to doctors for management of diabetes alongside feedback on positive eye exams for DR can improve diabetes care outcomes.\n\nThe main questions it aims to answer are:\n\n1. Does delivery of specific diabetes management recommendations to diabetes doctors for patients of theirs found to have DR lead to significantly improved blood glucose control as indicated by % reaching WHO targets of HbA1c (or targets for blood sugar if HbA1c data are unavailable)?\n2. What is the cost-effectiveness of the intervention, measured as total intervention cost per additional participant reaching the WHO target?\n\nResearchers will compare participant adherence with international guidelines when DR results are provided by a PIS without specific care recommendations to when the PIS provides DR results with specific care recommendations for DM management.",[414,27],"Diabetes Mellitus","2025-09-04",{"date":417,"type":32},"2025-09-11",{"date":419,"type":32},"2025-08-25",{"date":421,"type":21},"2026-12",{"name":423,"class":39},"Orbis",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":408,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":437,"leadSponsor":438,"locationsCount":40},"100590530","improving-patient-centered-care-for-diabetes-in-bangladesh-through-dynamic-integration-of-vision-care-on-the-demand-side-100590530","NCT06968611","Improving Patient-centered Care for Diabetes in Bangladesh Through \"Dynamic Integration\" of Vision Care on the Demand Side","Inclusion Criteria:\n\n* Diagnosed with DM within the last 6 months\n* Over 30 years of age\n* Currently treated at the Dinajpur Diabetes Hospital\n* Possess a mobile phone to receive voice messages\n* Willingness to participate in the study, and ability to give informed consent\n\nExclusion Criteria:\n\n* Other significant causes of vision loss\n* Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)",{"count":431,"type":21},640,[52],"The goal of this clinical trial is to determine whether there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improved quality of patient-centered diabetic care resulting from the use of automated voice message reminders to sensitize people with DM about the potential for sight loss alongside the provision of free reading glasses.\n\nThe main questions it aims to answer are:\n\n1. Will the proportion of patients completing their scheduled DR and DM appointments within 3 weeks of the scheduled date be significantly increased in the group receiving the automated voice messages containing both appointment reminders and messaging about the importance of visit and medication compliance in reducing the risk of vision loss, compared with participant messages which only remind them of their appointments?\n2. What is the cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam?",[414,27],{"date":417,"type":32},{"date":419,"type":32},{"date":421,"type":21},{"name":423,"class":39},{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":74,"sex":16,"minAge":447,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":450,"conditions":451,"keywords":458,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":66},"100603365","my-eyes-my-light-amar-chokh-amar-alo-100603365","NCT07135570","\"My Eyes, My Light\": Amar Chokh, Amar Alo","Stop Blindness in Coastal Bangladesh: Testing the Effectiveness of Community-Based, Artificial Intelligence-Assisted Eye Disease Screening in Coastal Bangladesh","ACA2","Inclusion Criteria:\n\n* Age 35+ years\n* Residing in the Sub-District of Char Fasson in the Bhola District\n\nExclusion Criteria:\n\n* Known eye disease diagnosis","35 Years",{"count":449,"type":21},20000,"Eye disease affects 2.2 billion people globally, which in turn adversely affects schooling, economic productivity, and participation in social life. The primary conditions contributing to visual impairment and blindness include cataracts, age-related macular degeneration (AMD), glaucoma, diabetic retinopathy (DR), refractive error, and presbyopia. Early detection of eye disease can provide substantial benefits in prompting treatment to reduce progression and mitigate disability.\n\nCompared with other regions, South Asia has the most cases of visual impairment due to cataracts and uncorrected refractive error. The combination of poverty, poor living and working environments, and limited health care access have long endangered eye health in Bangladesh. Coastal Bangladesh is particularly impacted by eye disease due to economic deprivation and limited healthcare access. The coastal population mostly works in fishing and agriculture, have prolonged sunlight exposure, and inadequate occupational eye protection. This low-lying region, with 35 million people, is especially vulnerable to climate disasters and global warming. High rates of chronic disease, especially diabetes mellitus Type 2 and hypertension, coupled with limited screening and treatment, shape the area's health profile, with the increasing prevalence of eye diseases such as DR, glaucoma, and visual impairment.\n\nTo address the issues of poor health, accessibility, and affordability of eye care, Artificial Intelligence (AI) applications, such as Artificial Intelligence (AI)-assisted fundus imaging, can be applied in eye screening. Medical AI applications have the potential to improve the quality and efficiency of healthcare, reduce healthcare costs, optimize treatment plans, and bolster the development of primary healthcare. They can identify presumptive DR, hypertensive retinopathy (HR), AMD, and glaucoma by analyzing the retina and optic disc of fundus images with moderate accuracy and high efficiency, thus helping address the lack of local eye care professionals.\n\nData Yakka developed a human-AI collaboration that delivers affordable and transformative community-based eye screening to underserved communities in the coastal Bangladesh region of Char Fasson. The \"Amar Chokh Amar Alo\" (My Eyes, My Light) initiative creates and implements comprehensive eye screening that combines AI-assisted eye screening and grassroots partnerships with trusted non-health non-governmental organizations (NGOs). It has three objectives: 1) Enhancing accessibility and affordability of eye screening; 2) Supporting high quality and efficient treatment of those problems detected via screening, 3) Collecting fundus images to refine or train AI algorithms in the future. This project was designed to evaluate the feasibility, performance, equity, and cost of this model of eye screening and its implications for global eye disease.\n\nThe implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Based on risk stratification by diabetes, hypertension, age 50+ years, and\u002For optometrist recommendation, fundus imaging was offered selectively to higher-risk patients.",[192,27,452,194,453,454,455,456,457],"Hypertensive Retinopathy","AMD - Age-Related Macular Degeneration","Presbyopia","Myopia","Hyperopia","Dacryocystitis",[459,460,461,462,463,464,465],"vision care","eye disease screening","cataracts","glaucoma","age-related macular degeneration","refractive error","Bangladesh","2025-08-19",{"date":468,"type":32},"2025-08-22",{"date":470,"type":32},"2025-01-05",{"date":472,"type":21},"2026-06",{"name":474,"class":123},"Data Yakka, Inc.",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":74,"sex":16,"minAge":17,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":66},"100600541","multimodal-biomarkers-in-prediction-of-diabetic-retinopathy-100600541","NCT07098832","Multimodal Biomarkers in Prediction of Diabetic Retinopathy","Application of Multimodal Biomarkers in Early Diagnosis and Progression Prediction of Diabetic Retinopathy: A Prospective Cohort Study","ZOCDR","Inclusion Criteria:\n\n* Participants must understand the clinical trial, voluntarily participate, and sign the informed consent form.\n* Aged 18-80 years, with no restriction on gender.\n* Healthy control group: No history or diagnosis of diabetes.\n* Diabetic group:\n\n  i) Definite diagnosis of diabetes. Both type 1 and type 2 diabetic patients will be included in this study.\n\nii) Based on dilated fundus examination, subjects are classified into NDR, NPDR, and PDR groups according to the staging of diabetic retinopathy.\n\n* Idiopathic epiretinal membrane (iERM) group is set as the control group for intraocular specimen collection and analysis in PDR patients: Funduscopic examination shows gold foil-like reflection or glass membrane-like substance covering the macular area, causing local retinal folds, with or without tortuosity and deformation of small perimacular blood vessels; OCT examination reveals a hyperreflective band on the retinal surface of the macular area; meeting the indications for pars plana vitrectomy combined with internal limiting membrane-epiretinal membrane peeling: visual acuity \\\u003C 0.3, or visual acuity \\> 0.5 but accompanied by progressive vision loss, severe metamorphopsia, diplopia, visual field defect, or other symptoms that significantly affect quality of life, and surgical treatment can be performed if actively requested by the patient; no diagnosis or history of diabetes.\n\nExclusion Criteria:\n\n* Complicated with other severe ocular diseases (e.g., glaucoma, age-related macular degeneration, uveitis, etc.).\n* A history of previous ocular surgery.\n* Complicated with severe systemic diseases (e.g., ischemic heart disease, stroke, malignant tumor, and severe liver or kidney diseases) or a history of systemic surgery (e.g., coronary artery bypass grafting, arterial\u002Fvenous thrombolysis, organ transplantation, etc.).\n* Complicated with cognitive impairment (MMSE score \\\u003C 24), mental illness (e.g., schizophrenia, bipolar disorder), or inability to cooperate with questionnaires and ophthalmic examinations due to language comprehension deficits.","80 Years",{"count":485,"type":21},1538,"The goal of this observational study is to enroll diabetic patients with diabetic retinopathy and those without diabetic retinopathy, follow up and observe the long-term changes in ocular structure and function of the subjects by comparison, analyze their association with multimodal biomarkers, and explore new methods for the early diagnosis and risk prediction of diabetic retinopathy.\n\nParticipants will be followed up over a 5-year follow-up period, during which they will undergo ophthalmic examinations, blood tests, and questionnaires.",[27],[166,489,490],"Prospective cohort","Multimodal biomarker","2025-07-30",{"date":291,"type":32},{"date":494,"type":21},"2025-07",{"date":496,"type":21},"2030-12",{"name":498,"class":39},"Zhongshan Ophthalmic Center, Sun Yat-sen University",{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":385,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":66},"100580914","effectiveness-and-cost-effectiveness-evaluations-of-ai-assisted-diagnostic-software-verisee-for-ophthalmic-disease-screening-100580914","NCT06843499","Effectiveness and Cost-Effectiveness Evaluations of AI-Assisted Diagnostic Software (VeriSee) for Ophthalmic Disease Screening",{"count":505,"type":21},1000,[52],"This study aims to evaluate the effectiveness of an artificial intelligence (AI)-assisted screening system in ophthalmic diagnosis. Using AI-based fundus photography, the system will assist physicians in diagnosing three common eye diseases: age-related macular degeneration and diabetic retinopathy (DR). The AI system will analyze fundus images from participants and rapidly generate detection results for ophthalmologists' reference in making final diagnoses and clinical decisions. The study will assess the clinical benefits of the AI-assisted diagnostic system, providing scientific evidence to enhance the efficiency of ophthalmic disease diagnosis and treatment.",[55,27],[341,510,511,512,138],"imaging analysis","disease diagnosis","macular degeneration","2025-06-17",{"date":515,"type":32},"2025-06-22",{"date":517,"type":32},"2025-06-02",{"date":399,"type":21},{"name":401,"class":39},{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":74,"sex":16,"minAge":526,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":4},"100593186","research-on-a-new-intelligent-mobile-screening-and-diagnosis-pattern-for-ocular-diseases-100593186","NCT07003165","Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases","Inclusion Criteria:\n\n* Age ≥ 7 years\n* Voluntary informed consent\n\nExclusion Criteria:\n\n-Inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.","7 Years",{"count":188,"type":21},"The global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. With the development of artificial intelligence and other technologies, it provides technical support for the construction of intelligent mobile screening model for eye diseases. The investigator's team has developed the 5G intelligent ophthalmic vehicle and served tens of thousands of people in 108 cities nationwide, initially verifying the feasibility of the new intelligent mobile screening model. However, the application effect, acceptance and influencing factors of this model in different regions are not clear, and there is a lack of economic benefit analysis based on real-world data. In this study, the investigators will conduct a cross-sectional study of large-scale population screening for blinding eye diseases in grassroots areas through the smart mobile screening model, focusing on the screening effectiveness and cost-effectiveness of the smart mobile screening model, integrating real-world multimodal eye health data, developing multiple smart screening analysis models, and exploring its adaptability and direction of improvement in grassroots areas.",[530,194,531,27,532],"Ophthalmic Diseases (Specific Types Not Restricted)","Refraction Error","Age Related Macular Degeneration (ARMD)","2025-06-03",{"date":535,"type":32},"2025-06-04",{"date":494,"type":21},{"date":538,"type":21},"2029-05",{"name":498,"class":39},{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":483,"enrollmentInfo":547,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":66},"100586392","investigating-the-metabolic-and-lipidomic-profiles-that-are-associated-with-varying-grades-of-diabetic-maculopathy-and-retinopathy-in-south-wales-100586392","NCT06914778","Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales","IMLADRIS","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Male or female aged 18 - 80 inclusive\n\nExclusion Criteria:\n\n* Participant unable or unwilling to consent to inclusion in the study\n* Prior treatment with intravitreal therapies for DMO\n* Potential participant with a known infective disease that may put the study team at risk (eg. TB, HIV, hepatitis)\n* Age 17 yo or less or 81 yo or older\n* Known underlying genetic condition affecting lipid metabolism",{"count":548,"type":21},120,"Diabetes mellitus is a disorder of sugar and fat metabolism which results in damage to the small blood vessels in various organs, this includes the retina - the part of the eye that processes light into a nerve impulse. This leads to damage and blindness via various different mechanisms that are not fully understood.\n\nIn this study the objective is to recruit people with diabetes and various stages of diabetic eye disease and measure a large number of different chemicals within the blood that might be associated with damage and dysfunction within the retina. Additionally, it will examine the different bacteria within the gut that might affect disease in the eye via chemicals circulating in the blood. This will require participants to have blood samples taken and to provide urine samples. The blood will be analysed with specialised instruments to identify specific molecules circulating within the blood. Participants will also need to allow researchers to look at their medical records, previous photographs and specialist scans of the back of the eye to grade their diabetic retinopathy. This will allow us to identify potential ways in which these could be targeted for future benefit for people with diabetes to hopefully prevent deterioration of their vision.",[27,286,164],[138,552,140,553,554],"lipidomics","diabetic maculopathy","metabolomics","2025-04-08",{"date":557,"type":32},"2025-04-10",{"date":559,"type":32},"2025-03-31",{"date":561,"type":21},"2030-01-01",{"name":563,"class":39},"Hywel Dda Health Board",{"id":565,"slug":566,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":584,"locationsCount":66},"100585883","functional-assessments-in-vision-impairment-100585883","NCT06908161","Functional Assessments in Vision Impairment","A Novel Approach for Capturing Real-world Functional Assessment Outcomes in Participants With a Vision Impairment","Inclusion Criteria:\n\n1. Willing to provide signed informed consent.\n2. Be available for study visits.\n3. Willing to comply with study assessments.\n4. In good general health and ambulant.\n5. Aged over 18 years of age.\n6. Have a vision impairment caused by any ocular condition which affects independent mobility.\n7. Agree to allow the research team into their home and local environments.\n8. Participate in assessments in public settings\n\nExclusion Criteria:\n\n1. Significant co-morbidities which prohibit involvement in study visits.\n2. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.\n3. Cognitive deficiencies, including dementia or progressive neurological disease.\n4. Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder.\n5. Deafness or significant hearing loss.\n6. Inability to converse in English.",{"count":572,"type":21},45,"The aim of the research project is to validate the use of a novel functional assessment tool designed to document how participants with a vision impairment complete activities of daily living in a real world environment.",[575,27,576,192,577],"Retinitis Pigmentosa (RP)","Age Related Macular Degeneration (AMD)","Retinal Dystrophy","2025-03-26",{"date":580,"type":32},"2025-04-03",{"date":582,"type":21},"2025-04-01",{"date":399,"type":21},{"name":585,"class":39},"Center for Eye Research Australia"]