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To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes.

NCT07425496 · The New York Eye & Ear Infirmary
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Official title
Dynamic Ocular Tonometry Study During Intraocular Surgery
About this study
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. This 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/or 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.
Eligibility criteria
Inclusion Criteria: * Individuals undergoing cataract and/or glaucoma surgery in the Mount Sinai Health System. Exclusion Criteria: * Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.
Study design
Enrollment target: 150 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-08-26
Estimated completion: 2028-12
Last updated: 2026-02-24
Interventions
Diagnostic Test: disposable Deltran I pressure sensor
Primary outcomes
  • Intraocular Pressure (IOP) measurement calculation during surgery. (90 days)
  • Outflow capacity calculation during surgery (90 days)
Sponsor
The New York Eye & Ear Infirmary · other
Contacts & investigators
ContactGautam Kamthan, MD · contact · gautam.kamthan@mountsinai.org · 212-979-4000
All locations (1)
New York Eye and Ear Infirmary of Mount SinaiRecruiting
New York, New York, United States
To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes. · TrialPath