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NCT07425496Recruiting

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

The New York Eye & Ear Infirmary

Start Date

8/26/2025

Completion Date

12/1/2028

Summary

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.

Detailed Description

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

Age Range: 18 years to No maximum

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.

Interventions

DIAGNOSTIC_TEST

disposable Deltran I pressure sensor

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Conditions

CataractGlaucoma

Locations

New York Eye and Ear Infirmary of Mount Sinai

New York, New York 10003

United States