NCT07425496

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: The New York Eye & Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-26
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2026-02-23
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States