[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522205":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":11,"responsibleParty":40,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gasless Surgery","EXPERIMENTAL",null,[13],"Procedure: Gasless Macular hole surgery",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard surgery with gas tamponade","ACTIVE_COMPARATOR",[18],"Procedure: Standard Macular hole surgery",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Gasless Macular hole surgery","Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane flap and ophthalmic viscosurgical device covering",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Standard Macular hole surgery","Pars plana vitrectomy to treat full thickness macular hole, with internal limiting membrane peel, and C2F6 tamponade",[15],[30],{"name":31,"affiliation":32,"role":33},"Timothy Jackson, PhD, FRCOphth","King's College London & King's College Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"George Murphy, MB BCh BAO, FRCOphth","CONTACT","(+)44 2032991297 ext 31297","george.murphy4@nhs.net",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[43],{"name":44,"class":45},"National Institute for Health Research, United Kingdom","OTHER_GOV","100522205","gasless-macular-hole-surgery-100522205",false,"NCT06079593","GaslEss Macular Hole Surgery","GaslEss Macular Hole Surgery (GEM): a Feasibility Study","GEM","Inclusion Criteria:\n\n* Requiring PPV to treat idiopathic (primary) FTMH.\n* 18 years or older\n* ETDRS BCVA letter score of 1 or better in the study eye\n* Able to provide written informed consent\n\nExclusion Criteria:\n\nGeneral:\n\n* Hypersensitivity to hyaluronate or other components of Healon Pro® viscoelastic\n* Any major illness or major surgical procedure within 4 weeks\n* Any other condition that, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol\n\nStudy eye\n\n* Previous vitreoretinal surgery, retinopexy, open-globe injury, or endophthalmitis\n* Presence of fibrotic retinal proliferation or central epiretinal membrane (within 1 disc diameter of the fovea)\n* Aphakia\n* Current or former myopia greater than 6 dioptres\n* Current or previous posterior uveitis or choroiditis\n* Presence of other ocular co-morbidity that, in the opinion of the investigator, is likely to impair BCVA postoperatively or affect FTMH closure\n* Current ocular or periocular infection, other than mild or moderate blepharitis\n* Lens or media opacity that preclude adequate retinal assessment and imaging","ALL","18 Years","100 Years",{"count":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"NA","Macular holes are a hole in the centre of the retina, the light-sensing layer in the back of the eye. They cause a central 'blind spot' in the vision, which can be very disabling for patients. Standard surgery involves injecting a large gas bubble inside the eye. This takes 4-8 weeks to leave the eye. During this time vision is greatly reduced in the eye. This limits patients' ability to drive and work. Gas causes clouding of the natural lens in the eye (cataract). The gas can also raise pressure inside the eye, causing pain and sometimes loss of vision. Patients cannot fly or have certain medicines until the gas absorbs.\n\nCritically, most patients position face down for 50 minutes out of every hour for a week after surgery. This is to float the gas bubble onto the macula. Head positioning is particularly difficult. It very often causes pain in the neck, back, arms and legs. Rarely, blood clots can form in the legs and be life-threatening if they dislodge and travel to the lungs. Head positioning also places a large burden on those caring for the patient.\n\nThe gases are 'greenhouse' gases and cause damage to the environment, for about 3,200 years.\n\nThis study looks at a new surgical technique for treating macular holes. The new technique aims to make patients' recovery from surgery easier, and safer.\n\nThe purpose of this study therefore is to compare two treatments:\n\n* Standard macular hole surgery with gas tamponade\n* Novel macular hole surgery without tamponade Gathering feasibility data to inform a future fully powered trial",[65],"Macular Holes","NOT_YET_RECRUITING","2023-12-08",{"date":69,"type":70},"2023-12-14","ACTUAL",{"date":72,"type":59},"2024-01-01",{"date":74,"type":59},"2026-10-31",{"name":5,"class":6}]