[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06539637":3,"trial-entities:NCT06539637":81,"trial-summary:NCT06539637":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":14,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":73,"overall_officials":76,"references":79,"see_also_links":80},"NCT06539637","00068701","Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% \u002F Ketorolac 0.3%","RECRUITING","2026-02","2024-08","2024-08-06","2023-09-01","DHS Consulting","OTHER",null,"This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% \u002F ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery\u002Fpars plana vitrectomy.","Cataract surgery can result in intra- and postoperative inflammation. Various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical NSAIDs, intraoperative NSAIDs or steroids, and postoperative topical NSAIDs and\u002For steroids. The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA® (Rayner Surgical, Bellevue, WA, USA).\n\nAnimal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery.\n\nThis study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.",[18],"Cataract",[],"INTERVENTIONAL","TREATMENT",[23],"EARLY_PHASE1",{"count":25,"type":26},20,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"COMBINATION_PRODUCT","OMIDRIA (*Registered Product) {10.16 mg\u002FmL (1% w\u002Fv) of phenylephrine and 2.88 mg\u002FmL (0.3% w\u002Fv) of ketorolac}","10.16 mg\u002FmL (1% w\u002Fv) of phenylephrine {Generic Name: Biorphen} (Adrenergic Receptor Agonist) and 2.88 mg\u002FmL (0.3% w\u002Fv) of ketorolac {Generic Name: TORADOL} (Nonsteroidal Anti-inflammatory) - via intracameral delivery",[33],"OMIDRIA",{"type":13,"name":35,"description":36,"armGroupLabels":37},"Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop","Topical ketorolac tromethamine {TORADOL, Nonsteroidal Anti-inflammatory} (0.5%) administered 4 times daily for the 3 days leading up to surgery. The last drop is to be given at least 2 hours prior to surgery.",[38],"Topical Ketorolac",[40],{"measure":41,"description":42,"timeFrame":43},"Concentration of ketorolac in the vitreous humor","Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients.","The day of surgery",[],"ALL","18 Years",false,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Undergoing cataract surgery immediately followed by pars plana vitrectomy\n3. Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)\n4. Willing and able to comply with all study procedures\n5. Male or female, aged ≥ 18 years\n\nExclusion Criteria:\n\n1. Age \\\u003C 18\n2. Participating in another clinical trial\n3. Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)\n4. Previous vitrectomy\n5. Complications at the time of cataract surgery\n6. A tear in the posterior capsule",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":70},"Ophthalmic Consultants of Long Island","Westbury","New York","11590","United States",[63,67],{"name":64,"role":65,"phone":66},"Eric Donnenfeld, MD","CONTACT","516-804-5200",{"name":68,"role":65,"phone":69},"Eric Sigler, MD","516 804 5200",{"lat":71,"lon":72},40.75566,-73.58763,[74],{"name":64,"role":65,"phone":69,"email":75},"ericdonnenfeld@gmail.com",[77],{"name":64,"affiliation":57,"role":78},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[18],[],{"nct_id":4,"found":85,"summary":86,"prompt_version":96},true,{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This interventional study plans to enroll 10-20 participants. It is not specified if it is randomized or blinded.","completed","Ketorolac Levels in Eye Fluid During Cataract and Vitrectomy Surgery","This study is looking at how much ketorolac, a medication to reduce inflammation, gets into your eye fluids (vitreous and aqueous humor) during combined cataract and vitrectomy surgeries. Researchers want to see if there's a difference in ketorolac levels when it's given as an injection during surgery (OMIDRIA) compared to eye drops (TORADOL) given before surgery. This information can help doctors understand how well these medications work to prevent inflammation after eye surgery. You may be able to join if you are an adult needing both cataract surgery and a vitrectomy for conditions like an epiretinal membrane or macular hole.","Ketorolac concentration in the vitreous humor will be measured on the day of surgery.",100,"You would undergo combined cataract surgery and pars plana vitrectomy. Eye fluid samples will be taken during your surgery for analysis.","Not stated in the trial record.",[],"v2"]