[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658587":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":47,"overallOfficials":57,"centralContacts":65,"locations":75,"responsibleParty":102,"collaborators":104,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":26,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":26,"enrollmentInfo":116,"targetDuration":26,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":132,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Wills Eye","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Visual Acuity","Best Corrected Visual Acuity","6 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Anatomic Success Rate","Maintenance of retinal attachment and normal retinal structure. Assessed via clinical eye examination, Optical Coherence Tomography Imaging and Fundus autofluorescence.",{"measure":18,"description":19,"timeFrame":12},"Ellipsoid Zone disruption","Examination of presence, and extent of, ellipsoid zone disruption via Optical Coherence Tomography.",{"measure":21,"description":22,"timeFrame":12},"Retinal Displacement","Assessment of presence, and extent, of retinal displacement via clinical eye examination, Optical Coherence Tomography and Fundus autofluorescence",{"measure":24,"description":25,"timeFrame":12},"Metamorphopsia","Assessment of presence, and extent of, metamorphopsia via M-chart examination.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","Macula-off rhegmatogenous retinal detachment (RRD) is associated with compromised visual outcomes. While current standard-of-care therapies (pars plana vitrectomy and scleral buckle) are highly effective at correcting the anatomy, functional visual recovery remains variable. Time to macular reattachment and the extent of retinal reapposition are critical factors influencing ultimate visual acuity.\n\nSmall preliminary studies suggest that an intraocular gas injection performed prior to definitive surgical treatment may decrease the duration of macular detachment and minimize retinal displacement, potentially improving visual outcomes. However, there are currently no randomized controlled trials available to validate this approach.\n\nThis randomized study aims to determine if a preoperative injection of 0.3 cc of 100% C3F8 gas prior to standard surgical therapy for macula-off RRD results in superior visual acuity compared to the standard of care alone. By evaluating whether preoperative gas injection effectively shortens the duration of macular separation and reduces retinal displacement, this study seeks to demonstrate a clear visual benefit. Positive findings could change clinical management, establishing a new standard of care and significantly improving the visual prognosis for patients presenting with macula-off RRD.",[35,42],{"label":36,"type":37,"description":38,"interventionNames":39},"Preoperative Gas","EXPERIMENTAL","Patients in this group will be injected with 0.3 cc of 100% C3F8 gas prior to surgical repair of the retinal detachment.",[40,41],"Procedure: Intravitreal 100% C3F8 Injection","Procedure: Pars plana vitrectomy or pars plana vitrectomy with scleral buckle",{"label":43,"type":44,"description":45,"interventionNames":46},"Standard of Care","ACTIVE_COMPARATOR","Patients in this arm will receive standard of care treatment with Pars Plana Vitrectomy or Pars Plana vitrectomy with Scleral Buckle.",[41],[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":26},"PROCEDURE","Intravitreal 100% C3F8 Injection","Patients with Macula off Rhegmatogenous Retinal Detachment will receive an intravitreal injection of 100% C3F8 prior to undergoing surgical repair for their condition",[36],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":26},"Pars plana vitrectomy or pars plana vitrectomy with scleral buckle","Patients with RRD will undergo standard of care treatment of RRD with pars plana vitrectomy or pars plana vitrectomy with scleral buckle",[36,43],[58,62],{"name":59,"affiliation":60,"role":61},"Ajay Kuriyan, MD","Wills Eye Hospital","PRINCIPAL_INVESTIGATOR",{"name":63,"affiliation":64,"role":61},"Sidra Zafar, MD","The Johns Hopkins Wilmer Eye Institute",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":26,"email":70},"Omar Masoud, MD","CONTACT","4452133130","omasoud@willseye.org",{"name":72,"role":68,"phone":73,"phoneExt":26,"email":74},"Zainab Rustam, MD","6674147808","zrustam2@jhmi.edu",[76,91],{"facility":77,"status":26,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Wilmer Eye Institute, Johns Hopkins Hospital","Baltimore","Maryland","21287","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-76.61219,39.29038,{"lat":87,"lon":86},[90],{"name":72,"role":68,"phone":73,"phoneExt":26,"email":74},{"facility":60,"status":26,"city":92,"state":93,"zip":94,"country":81,"countryCode":82,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Philadelphia","Pennsylvania","19107",{"type":84,"coordinates":96},[97,98],-75.16362,39.95238,{"lat":98,"lon":97},[101],{"name":67,"role":68,"phone":69,"phoneExt":26,"email":70},{"type":103,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[105],{"name":106,"class":6},"Johns Hopkins University","100658587","phase-2-use-of-preoperative-gas-in-eyes-with-macula-off-rhegmatogenous-retinal-detachment-rrd-100658587",false,"NCT07855770","Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)","A Prospective, Randomized Study on the Use of Preoperative Gas in Eyes With Macula-off Rhegmatogenous Retinal Detachment (RRD)","Inclusion Criteria:\n\n* A patient must meet the following criteria to be eligible for inclusion in the study: 1. Diagnosed with macula-involving primary rhegmatogenous retinal detachment 2. Consents to surgical repair with pars plana vitrectomy with or without scleral buckling 3. Willing and able to comply with clinic visits and study-related procedures\n\nExclusion Criteria:\n\n* A patient who meets any of the following criteria will be excluded from the study: 1. Age \\\u003C 18 years old 2. Presence of PVR grade C or worse (as defined by the revised Retina Society PVR classification) at time of surgical repair 3. History of or concurrent ruptured globe, intraocular foreign body, proliferative diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular epiretinal membrane, sickle cell disease, uveitis or intraocular infectious diseases 4. Not willing or able to comply with clinic visits and study-related procedures 5. Unable to provide a signed informed consent 6. Unable to maintain positioning to support break 7. Patients that undergo silicone oil placement for primary macula-off RRD 8. For bilateral macula-off RRDs, the better seeing eye will be excluded.","ALL","18 Years",{"count":117,"type":118},190,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE2","PHASE3","The purpose of this study is to evaluate whether a preoperative intraocular gas injection improves visual outcomes in patients with a macula-off rhegmatogenous retinal detachment (RRD). While current surgical therapies successfully reattach the retina, visual recovery can vary. This study will investigate if injecting a small amount of gas (0.3 cc of 100% C3F8) into the eye prior to standard surgery can decrease the duration of macular detachment, reduce retinal displacement, and ultimately result in better final visual acuity compared to the standard of care alone.",[125],"Retinal Detachment Rhegmatogenous",[127,128,129,130,131],"Retinal Detachment","Rhegmatogenous Retinal Detachment","Scleral Buckle","Pars Plana Vitrectomy","C3F8 Gas","NOT_YET_RECRUITING","2026-09-28",{"date":135,"type":136},"2026-10-02","ACTUAL",{"date":138,"type":118},"2026-09-21",{"date":140,"type":118},"2029-03",{"name":5,"class":6},2]