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

February 20, 2026 updated by: The New York Eye & Ear Infirmary

Dynamic Ocular Tonometry Study During Intraocular Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • New York Eye and Ear Infirmary of Mount Sinai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be stratified according to disease entity (glaucoma and/or cataract), severity (mild, moderate, etc), and surgery performed (cataract surgery, cataract surgery combined with glaucoma surgery, trabeculectomy, and/or glaucoma device implantation).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cataract
disposable Deltran I pressure sensor for Cataract
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.
Glaucoma
disposable Deltran I pressure sensor for Glaucoma
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of intraoperative and postoperative complications.
Time Frame: 90 days
Percentage rate of intraoperative and postoperative complications.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New York Eye & Ear Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Sherwood JM, Reina-Torres E, Bertrand JA, Rowe B, Overby DR. Measurement of Outflow Facility Using iPerfusion. PLoS One. 2016;11(3):e0150694. Published 2016 Mar 7.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-00501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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