[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-operative-inflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-operative-inflammation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100391014","phase-4-dextenza-in-the-post-op-management-of-vitreoretinal-surgeries-100391014",false,"NCT04371445","Dextenza in the Post-op Management of Vitreoretinal Surgeries","Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery","Inclusion Criteria:\n\n* Men and women \\>18 years old\n* Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.\n\nExclusion Criteria:\n\n* Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and\u002For implant of a drug delivery system\n* History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye\n* Structural lid abnormalities such as ectropion or entropion in surgical eye\n* Ongoing use of systemic narcotic pain relievers\n* Presence of any intraocular inflammation (cells and flare) in the study eye at screening\u002Fbaseline\n* Pain score greater than \"0\" on the ocular pain assessment in the study eye at screening\u002Fbaseline\n* Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes\n* Other ocular surgeries or procedures during the study period and\u002For 6 months prior\n* Intraoperative complications\n* Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.\n* Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.\n* Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.\n* Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.\n* Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure\n* Are pregnant or nursing\u002Flactating\n* Participation as a subject in any clinical study within the 30 days prior to randomization.\n* Surgeries using 20 gauge or 23 gauge instruments.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.\n\nPatients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.",[26,27,28,29],"Vitreoretinal Surgery","Ocular Inflammation","Post-operative Pain","Post-Operative Inflammation",[31,27,29,28],"dexamethasone insert","RECRUITING","2026-02-06",{"date":35,"type":36},"2026-02-10","ACTUAL",{"date":38,"type":36},"2020-06-01",{"date":40,"type":20},"2026-05-01",{"name":42,"class":43},"The Cleveland Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100404713","phase-4-the-prime-study-a-randomized-controlled-prospective-study-100404713","NCT04549935","The PRIME Study: A Randomized, Controlled, Prospective Study","A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)","Inclusion Criteria:\n\n* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20\u002F30 or better\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients under the age of 22 or above the age of 75\n* Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).\n* Patients with active infectious ocular or extraocular disease.\n* Patients actively treated with local or systemic immunosuppression including systemic corticosteriods\n* Paitents with know hypersensitivity to Dexamethasone\n* Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator\n* Patients with a history of ocular inflammation or macular edema\n* Patients with allergy or inability to receive intracameral antibiotic\n* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg\u002Fday\n* Patient with a corticosteriod implant (i.e. Ozurdex).\n* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes",true,"22 Years","75 Years",{"count":56,"type":20},20,[23],"To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.",[60,61,29,62,63],"Patient Preference","Patient Outcomes","Grade of Post-Operative Cystoid Macular Edema","Rate of Post-Operative Cystoid Macular Edema","2020-09-14",{"date":66,"type":36},"2020-09-16",{"date":64,"type":20},{"date":69,"type":20},"2021-08-27",{"name":71,"class":43},"Vance Thompson Vision - MT"]