[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464743":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":54,"centralContacts":59,"locations":67,"responsibleParty":84,"collaborators":28,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":28,"enrollmentInfo":97,"targetDuration":28,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":69,"whyStopped":28,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","ACTIVE_COMPARATOR","* Subconjunctival antibiotic (cefazolin 50 mg\u002F0.5 mL, moxifloxacin 0.5 mg\u002F0.1 mL, or vancomycin 1 mg\u002F0.1 mL) and subconjunctival dexamethasone (4 mg\u002FmL) at the time of surgery\n* Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery\n* Topical moxifloxacin 0.5% or Polymyxin\u002FTrimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery.\n* Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4\u002F3\u002F2\u002F1 taper)\n* Topical atropine 1% daily for 1 week",[13,14,15,16],"Procedure: Pars plana vitrectomy","Drug: Moxifloxacin 0.5% or Polymyxin\u002FTrimethoprim if patient is allergic to moxifloxacin","Drug: Prednisolone 1%","Drug: Atropine 1%",{"label":18,"type":10,"description":19,"interventionNames":20},"Group 2","* Subtenon triamcinolone acetonide (40 mg\u002F1mLl) at the time of surgery\n* Subconjunctival antibiotic (cefazolin 50 mg\u002F0.5 mL, moxifloxacin 0.5 mg\u002F0.1 mL, or vancomycin 1 mg\u002F0.1 mL) and subconjunctival dexamethasone (4 mg\u002FmL) at the time of surgery\n* Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery\n* No postoperative eye drops",[13,21],"Drug: Triamcinolone Acetonide 40mg\u002FmL",[23,29,36,42,48],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Pars plana vitrectomy","Standard of care surgery",[9,18],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Triamcinolone Acetonide 40mg\u002FmL","Sub-tenon injection of triamcinolone acetonide (40mg\u002FmL) at the time of surgery",[18],[35],"Kenalog-40",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Moxifloxacin 0.5% or Polymyxin\u002FTrimethoprim if patient is allergic to moxifloxacin","Antibiotic eye drop 4 times per day for 1 week after surgery",[9],[41],"Vigamox or Polytrim",{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Prednisolone 1%","Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4\u002F3\u002F2\u002F1 taper) after surgery",[9],[47],"Pred forte",{"type":30,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Atropine 1%","Eye drop daily for 1 week after surgery",[9],[53],"Atropine sulfate",[55],{"name":56,"affiliation":57,"role":58},"Nimesh A. Patel, MD","Massachusetts Eye and Ear","PRINCIPAL_INVESTIGATOR",[60,64],{"name":56,"role":61,"phone":62,"phoneExt":28,"email":63},"CONTACT","617-523-7900","nimesh_patel2@meei.harvard.edu",{"name":65,"role":61,"phone":62,"phoneExt":28,"email":66},"Sandra Alhoyek, MD","salhoyek@meei.harvard.edu",[68],{"facility":57,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-71.05977,42.35843,{"lat":79,"lon":78},[82],{"name":83,"role":61,"phone":28,"phoneExt":28,"email":63},"Nimesh A Patel, MD",{"type":58,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Nimesh Patel","Principal Investigator","100464743","phase-4-dropless-pars-plana-vitrectomy-study-100464743",false,"NCT05331664","Dropless Pars Plana Vitrectomy Study","DVS","Inclusion Criteria:\n\n* Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)\n\nExclusion Criteria:\n\n* Need for concomitant lensectomy or cataract surgery\n* Pars plana vitrectomy taking place more than seven days after the initial diagnosis\n* History of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye\n* History of previous retinal detachment in surgical eye\n* History of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye\n* History of ocular laser surgery within 1 month in surgical eye\n* History of intravitreal injection within 1 month in surgical eye\n* Diagnosis of glaucoma or intraocular pressure more than 21 mmHg in either eye\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Previous history of steroid response\n* Current treatment with oral, topical, or intravitreal corticosteroids\n* Presence of proliferative vitreoretinopathy at the time of diagnosis\n* Presence of giant retinal tear at the time of diagnosis\n* Diagnosis of proliferative diabetic retinopathy\n* Anterior chamber inflammation on presentation in either eye\n* Signs of ocular infection at presentation in either eye\n* Acute external ocular infections\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* Inability to use or apply topical eye drops\n* Requirement for silicone oil as a tamponade agent\n* Individuals with impaired decision-making capacity\n* Non-English-speaking subjects",true,"ALL","40 Years",{"count":98,"type":99},168,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.",[105],"Rhegmatogenous Retinal Detachment",[107,108,109,110,111,112,113],"Vitrectomy","Dropless","Sub-tenon steroids","Postoperative","Inflammation","Randomized clinical trial","Non-inferiority trial","2026-06-23",{"date":116,"type":117},"2026-06-26","ACTUAL",{"date":119,"type":117},"2022-07-25",{"date":121,"type":99},"2027-01-30",{"name":5,"class":6},1]