CataractNCT07425496
To Study Ocular Outflow Dynamics of the Eye Using Intraoperative Tonographic Biometry and Assess Its Predictive Value in Improving Postoperative Outcomes.
An observational study of Cataract and Glaucoma, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- disposable Deltran I pressure sensor
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Individuals undergoing cataract and/or glaucoma surgery in the Mount Sinai Health System.
Who cannot join
- Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Principal Investigator, 212-979-4000, gautam.kamthan@mountsinai.org
About this study
Official title: 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.
Read the 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.
- Being tested
- disposable Deltran I pressure sensor
- Keywords
- glaucoma surgery, cataract, glaucoma
- Medical subject headings
- Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disposable Deltran I pressure sensorDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cataract | disposable Deltran I pressure sensor for Cataract Receives: Diagnostic Test: disposable Deltran I pressure sensor | |
| Glaucoma | disposable Deltran I pressure sensor for Glaucoma Receives: Diagnostic Test: disposable Deltran I pressure sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
Rate of intraoperative and postoperative complications.
Percentage rate of intraoperative and postoperative complications.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start26 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425496
- Sponsor's protocol ID
- 23-00501
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time.
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.
PubMed 26949939
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Ocular Tonometry Study During Intraocular Surgery
- ClinicalTrials.gov ID
- NCT07425496
- Acronym / sponsor ID
- 23-00501
- Keywords
- glaucoma surgery, cataract, glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract | – | Diagnostic Test: disposable Deltran I pressure sensordisposable Deltran I pressure sensor for Cataract |
| Glaucoma | – | Diagnostic Test: disposable Deltran I pressure sensordisposable Deltran I pressure sensor for Glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Individuals undergoing cataract and/or glaucoma surgery in the Mount Sinai Health System.
Key exclusion criteria (1 listed)
- Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disposable Deltran I pressure sensorIntraocular 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. | Diagnostic test | Cataract, Glaucoma |
Primary outcome
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.
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.
1 secondary outcome
Rate of intraoperative and postoperative complications.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 26949939Sherwood 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.
- Individual participant dataSharing planned: Undecided. Undecided at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Glaucoma, run by The New York Eye & Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gautam Kamthan, MD (212-979-4000, gautam.kamthan@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) measurement calculation during surgery. (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.