[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554388":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":23,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":23,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":109,"whyStopped":23,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketorolac Alone","EXPERIMENTAL","Participants in this arm will receive ketorolac 0.5% eye drops administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that helps reduce inflammation and alleviate pain. The purpose of this intervention is to assess the efficacy and safety of ketorolac alone in managing postoperative inflammation and patient comfort compared to other treatment strategies.",[13],"Drug: Ketorolac 0.5% Eye Drops",{"label":15,"type":10,"description":16,"interventionNames":17},"Ketorolac with Fluorometholone","Participants in this arm will receive a combination of ketorolac 0.5% eye drops administered twice daily and fluorometholone 0.1% eye drops administered four times daily for one week following Selective Laser Trabeculoplasty (SLT). Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. This arm aims to evaluate the combined efficacy and safety of ketorolac and fluorometholone in postoperative care.",[18],"Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops",{"label":20,"type":21,"description":22,"interventionNames":23},"No Treatment Control","NO_INTERVENTION","Participants in this arm will not receive any postoperative treatment following Selective Laser Trabeculoplasty (SLT). This control group is included to provide a baseline for comparison against the treatment groups receiving ketorolac alone or a combination of ketorolac and fluorometholone. The purpose is to assess the natural course of postoperative inflammation and patient comfort without intervention.",null,[25,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ketorolac 0.5% Eye Drops","Participants in this arm will receive ketorolac 0.5% eye drops, administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the inflammatory process. This intervention aims to reduce postoperative inflammation and pain, promoting patient comfort and potentially improving outcomes following SLT.",[9],[31,32,33],"Acular","Acular LS","Acuvail",{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops","Participants in this arm will receive a combination of ketorolac 0.5% eye drops and fluorometholone 0.1% eye drops. Ketorolac will be administered twice daily and fluorometholone four times daily for one week following SLT. Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. The combination aims to maximize anti-inflammatory effects and enhance patient comfort, potentially leading to better postoperative outcomes compared to ketorolac alone or no treatment.",[15],[39,31,33,40],"FML","Fluor-Op",[42],{"name":43,"affiliation":5,"role":44},"Enitan A Sogbesan, MD","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Sharan Bains, MD","CONTACT","(905) 573-7777","38504","bainss@mcmaster.ca",{"name":43,"role":48,"phone":49,"phoneExt":53,"email":51},"38311",[55],{"facility":56,"status":23,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute","Hamilton","Ontario","L8G 4X3","Canada","CA",{"type":63,"coordinates":64},"Point",[65,66],-79.84963,43.25011,{"lat":66,"lon":65},[69,71],{"name":47,"role":48,"phone":70,"phoneExt":50,"email":51},"905-522-1155",{"name":43,"role":48,"phone":72,"phoneExt":53,"email":73},"905-573-7777","sogbese@mcmaster.ca",{"type":44,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Enitan Sogbesan","Dr. Enitan Sogbesan, Principal Investigator","100554388","phase-4-efficacy-of-nsaid-vs-steroid-nsaid-combo-post-selective-laser-trabeculoplasty-phase-4-single-center-rct-100554388",false,"NCT06498440","Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT","Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled Trial","CES-NSLT","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Diagnosed with open-angle glaucoma.\n* Intraocular pressure (IOP) greater than 16 mmHg on at least two consecutive occasions separated by one month.\n* Visual acuity of 20\u002F200 or better in at least one eye.\n* Provided informed consent.\n\nExclusion Criteria:\n\n* Patients with any other ocular disorders or surgeries within the last six months.\n* Allergy or intolerance to ketorolac or fluorometholone.\n* Previous use of systemic ketorolac or fluorometholone in the past month.\n* Pregnancy or breastfeeding.\n* Patients who are unable to speak\u002Funderstand English.\n* Any condition that in the investigator's opinion would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified assessments.","ALL","18 Years",{"count":88,"type":89},126,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","This clinical trial, led by Dr. Enitan A. Sogbesan at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton, aims to compare the efficacy and safety of non-steroidal anti-inflammatory drug (NSAID) ketorolac alone versus a combination of ketorolac and the corticosteroid fluorometholone, and a control group receiving no postoperative treatment. The trial will evaluate these treatment strategies following Selective Laser Trabeculoplasty (SLT) in patients with open-angle glaucoma. The primary objective is to determine the most effective postoperative management strategy to reduce inflammation, improve patient comfort, and control intraocular pressure (IOP). Participants will be randomly assigned to one of the three groups, with follow-up visits scheduled at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year post-SLT. The study's findings aim to guide clinicians in optimizing postoperative care for better patient outcomes.",[95,96,97],"Open Angle Glaucoma","Ocular Hypertension","Postoperative Inflammation",[99,100,101,102,103,104,105,106,107,108],"Selective Laser Trabeculoplasty (SLT)","Non-steroidal anti-inflammatory drugs (NSAIDs)","Ketorolac","Fluorometholone","Postoperative care","Intraocular pressure (IOP)","Visual acuity","Glaucoma treatment","Ophthalmology","Randomized controlled trial (RCT)","NOT_YET_RECRUITING","2024-07-05",{"date":112,"type":113},"2024-07-12","ACTUAL",{"date":115,"type":89},"2024-09-01",{"date":117,"type":89},"2025-07-01",{"name":5,"class":6},1]