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
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2025
CompletedFirst Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 24, 2026
February 1, 2026
2.3 years
February 10, 2026
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intraocular Pressure (IOP) measurement calculation during surgery.
Measure the intra ocular pressure measurement during surgery to better inform surgeons of post-operative management and outcomes.
90 days
Outflow capacity calculation during surgery
Measure the outflow capacity rate measurement during surgery to better inform surgeons of post-operative management and outcomes.
90 days
Secondary Outcomes (1)
Rate of intraoperative and postoperative complications.
90 days
Study Arms (2)
Cataract
disposable Deltran I pressure sensor for Cataract
Glaucoma
disposable Deltran I pressure sensor for Glaucoma
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- Individuals undergoing cataract and/or glaucoma surgery in the Mount Sinai Health System.
You may not qualify if:
- Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003, United States
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 23, 2026
Study Start
August 26, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02