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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07425496

Enrollment

150

Registered

2026-02-23

Start date

2025-08-26

Completion date

2028-12-01

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma

Keywords

glaucoma surgery, cataract, glaucoma

Brief 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.

Interventions

DIAGNOSTIC_TESTdisposable 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Intraocular Pressure (IOP) measurement calculation during surgery.	90 days	Measure the intra ocular pressure measurement during surgery to better inform surgeons of post-operative management and outcomes.
Outflow capacity calculation during surgery	90 days	Measure the outflow capacity rate measurement during surgery to better inform surgeons of post-operative management and outcomes.

Secondary

Measure	Time frame	Description
Rate of intraoperative and postoperative complications.	90 days	Percentage rate of intraoperative and postoperative complications.

Countries

United States

Contacts

CONTACTGautam Kamthan, MD

gautam.kamthan@mountsinai.org212-979-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026