To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: disposable Deltran I pressure sensor.
- Who it may be relevant to
- Registry conditions: Cataract, Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dynamic Ocular Tonometry Study During Intraocular Surgery
Overview
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 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.
Primary outcome measures
- Intraocular Pressure (IOP) measurement calculation during surgery. [Time frame: 90 days]
- Outflow capacity calculation during surgery [Time frame: 90 days]
Secondary outcome measures (1)
- Rate of intraoperative and postoperative complications. [Time frame: 90 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- New York Eye and Ear Infirmary of Mount Sinai — New York
Publications
- Sherwood JM, Reina-Torres E, Bertrand JA, Rowe B, Overby DR. Measurement of Outflow Facility Using iPerfusion. PLoS One. 2016 Mar 7;11(3):e0150694. doi: 10.1371/journal.pone.0150694. eCollection 2016. PMID 26949939
Identifiers
NCT: NCT07425496 · 23-00501