Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

New York Eye and Ear Infirmary of Mount Sinai
New York 5128581, New York 5128638 10003
Contact:
Principal Investigator
212-979-4000
gautam.kamthan@mountsinai.org

More Details

Status
Recruiting
Sponsor
The New York Eye & Ear Infirmary

Study Contact

Gautam Kamthan, MD
212-979-4000
gautam.kamthan@mountsinai.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.