[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616143":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":73,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":25,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":25,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":111,"whyStopped":25,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single injection Group","ACTIVE_COMPARATOR","Intravitreal Aflibercept 2mg\u002F0.05ml injection will be given by standard technique at the end of Phacoemulsification with Intraocular lens implantation",[13],"Drug: Aflibercept (Eylea)",{"label":15,"type":16,"description":17,"interventionNames":18},"Multiple Injection Group","EXPERIMENTAL","This group will receive Aflibercept intravitreal injection 2mg\u002F0.05ml by standard technique at the end of the phacoemulsification with intraocular lens implantation and then at 1st, and 2nd months postoperatively.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Aflibercept (Eylea)","Single injection group will receive aflibercept intravitreal injection 2mg\u002F0.05ml by the standard technique at the end of phacoemulsification with intraocular lens implantation. Multiple injection group will receive aflibercept intravitreal injection 2mg\u002F0.05ml by standard technique at the end of phacoemulsification with intraocular lens implantation and then at 1st, and 2ndmonths postoperatively.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"AHMAD ZEESHAN JAMIL, FCPS, FRCS, FCPS(VRO)","Sahiwal Medical College and Sahiwal Teaching Hospital Sahiwal","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Ahmad Zeeshan Jamil, FCPS, FRCS, FCPS(VRO)","CONTACT","+92 333 4853851","ahmadzeeshandr@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Muhammad Hannan Jamil, FCPS, FRCS, FCPS(VRO)","+92 333 6113166","hannnan.jamil@ucm.uol.edu.pk",[42,59],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University College of Medicine and Dentistry (UCMD)","Lahore","Punjab Province","54000","Pakistan","PK",{"type":50,"coordinates":51},"Point",[52,53],74.35071,31.558,{"lat":53,"lon":52},[56,58],{"name":38,"role":34,"phone":39,"phoneExt":25,"email":57},"hannan.jamil@ucm.uol.edu.pk",{"name":38,"role":30,"phone":25,"phoneExt":25,"email":25},{"facility":60,"status":25,"city":61,"state":62,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Sahiwal Medical College and Sahiwal Teaching Hospital","Sahiwal","Punjab, Pakistan","57000",{"type":50,"coordinates":65},[66,67],73.10186,30.66595,{"lat":67,"lon":66},[70,72],{"name":71,"role":34,"phone":35,"phoneExt":25,"email":36},"AHMAD Zeeshan JAMIL, FCPS, FRCS, FCPS(VRO)",{"name":28,"role":30,"phone":25,"phoneExt":25,"email":25},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Ahmad Zeeshan Jamil","Professor and Head, Department of Ophthalmology",[78],{"name":79,"class":80},"Sahiwal medical college sahiwal","OTHER_GOV","100616143","phase-4-comparing-single-versus-multiple-anti-vegf-injections-in-diabetic-patients-undergoing-cataract-surgery-100616143",false,"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.","ALL","40 Years",{"count":91,"type":92},166,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","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.",[98,99,100,101,102],"Diabetic Retinopathy (DR)","Diabetic Macular Edema (DME)","Cataract","Phacoemulfisication+IOL Implantation","Intravitreal Injection",[104,105,106,102,107,108,109,110],"Vascular endothelial growth factor","Aflibercept","Cataract Extraction","Phacoemulsification","Diabetic retinopathy","Diabetic macular edema","Intraocular lens implantation","NOT_YET_RECRUITING","2025-12-10",{"date":114,"type":115},"2025-12-24","ACTUAL",{"date":117,"type":92},"2026-01-01",{"date":119,"type":92},"2026-09-30",{"name":75,"class":6},2]