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NCT Number: NCT07425496

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Eye and Ear Infirmary of Mount Sinai

New York, 10003, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

212-979-4000

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

disposable Deltran I pressure sensor

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Rate of intraoperative and postoperative complications.

    Time frame: 90 days

    Percentage rate of intraoperative and postoperative complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Gautam Kamthan, MD

CONTACT

[email protected]

212-979-4000

Sponsors and collaborators

Lead sponsor

The New York Eye & Ear Infirmary

Other

Registry information

Official study title

Dynamic Ocular Tonometry Study During Intraocular Surgery

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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