[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07425496":3,"trial-entities:NCT07425496":85,"trial-summary:NCT07425496":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":15,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":15,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":57,"locations":60,"central_contacts":75,"overall_officials":78,"references":79,"see_also_links":84},"NCT07425496","23-00501","To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes.","Dynamic Ocular Tonometry Study During Intraocular Surgery","RECRUITING","2028-12","2026-02","2026-02-24","2025-08-26","The New York Eye & Ear Infirmary","OTHER",null,"The objective of this study is to evaluate ocular outflow dynamics of the eye using intraoperative tonographic biometry and assess its predictive value in improving postoperative outcomes.","This study proposes to measure the intraocular pressure (IOP), ocular fluid dynamics and outflow homeostasis in patients undergoing intraocular surgery to understand how post-operative surgical success can be optimized and complications prevented.\n\nThis is a prospective observational study, single study arm and at a single-site. Recruitment will be from physicians affiliated with the Mount Sinai Health System who are performing intraocular surgeries, such as cataract and\u002For glaucoma surgeries. Intraocular pressure measurements will be taken using an FDA-registered, sterile, single-use, disposable Deltran I pressure sensor designed for measuring physiological pressures of the body to obtain concomitant intraocular measurement and outflow capacity calculation during the surgery. Monitoring intra ocular pressure postoperatively for up to 90 days.",[19,20],"Cataract","Glaucoma",[22,23,24],"glaucoma surgery","cataract","glaucoma","OBSERVATIONAL",[],{"count":28,"type":29},150,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","disposable Deltran I pressure sensor","Intraocular pressure measurements will be taken using an FDA-registered, sterile, single-use, disposable Deltran I pressure sensor designed for measuring physiological pressures of the body.",[19,20],[37,41],{"measure":38,"description":39,"timeFrame":40},"Intraocular Pressure (IOP) measurement calculation during surgery.","Measure the intra ocular pressure measurement during surgery to better inform surgeons of post-operative management and outcomes.","90 days",{"measure":42,"description":43,"timeFrame":40},"Outflow capacity calculation during surgery","Measure the outflow capacity rate measurement during surgery to better inform surgeons of post-operative management and outcomes.",[45],{"measure":46,"description":47,"timeFrame":40},"Rate of intraoperative and postoperative complications.","Percentage rate of intraoperative and postoperative complications.","ALL","18 Years",false,{"inclusion":52,"exclusion":54,"raw_text":56},[53],"Individuals undergoing cataract and\u002For glaucoma surgery in the Mount Sinai Health System.",[55],"Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.","Inclusion Criteria:\n\n* Individuals undergoing cataract and\u002For glaucoma surgery in the Mount Sinai Health System.\n\nExclusion Criteria:\n\n* Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":8,"city":63,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"New York Eye and Ear Infirmary of Mount Sinai","New York","10003","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Principal Investigator","CONTACT","212-979-4000","gautam.kamthan@mountsinai.org",{"lat":73,"lon":74},40.71427,-74.00597,[76],{"name":77,"role":69,"phone":70,"email":71},"Gautam Kamthan, MD",[],[80],{"pmid":81,"type":82,"citation":83},"26949939","BACKGROUND","Sherwood JM, Reina-Torres E, Bertrand JA, Rowe B, Overby DR. Measurement of Outflow Facility Using iPerfusion. PLoS One. 2016 Mar 7;11(3):e0150694. doi: 10.1371\u002Fjournal.pone.0150694. eCollection 2016.",[],{"nct_id":4,"conditions":86,"biomarkers":87},[19,20],[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an observational study with a single group of participants, taking place at one location. It plans to include 150 participants.","completed","Observational Study of Ocular Outflow in Cataract and Glaucoma Surgery","This observational study is looking at how fluid drains from the eye during cataract and\u002For glaucoma surgery. Researchers will use a special device called the disposable Deltran I pressure sensor to measure the pressure inside your eye and how well fluid flows out during your surgery. The goal is to understand if these measurements can help predict better outcomes after surgery and prevent problems. You may be able to join if you are 18 or older and are having cataract and\u002For glaucoma surgery at Mount Sinai Health System. The study will consider itself successful if it can calculate the eye pressure and outflow capacity during surgery, and then monitor eye pressure for 90 days after surgery. The current status of this study is unclear.","Participants will have their intraocular pressure monitored for up to 90 days after surgery.",124,"During your cataract and\u002For glaucoma surgery, intraocular pressure measurements will be taken using a disposable Deltran I pressure sensor. Your eye pressure will then be monitored for up to 90 days after surgery.","Not stated in the trial record.",[33],"v2"]