Measuring eye pressure and fluid outflow during cataract or glaucoma surgery
Dynamic Ocular Tonometry Study During Intraocular Surgery
This will test whether measuring eye pressure and fluid outflow during cataract or glaucoma surgery with a disposable sensor can help predict and improve recovery for adults having these operations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The New York Eye & Ear Infirmary Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07425496 on ClinicalTrials.gov |
What this trial studies
This prospective, single-arm observational study will use a sterile, single-use Deltran I pressure sensor to record intraoperative intraocular pressure and calculate outflow capacity in adults undergoing cataract and/or glaucoma surgery at the New York Eye and Ear Infirmary of Mount Sinai. Investigators will collect intraoperative tonographic biometry and follow postoperative intraocular pressure and clinical outcomes for up to 90 days. The goal is to correlate intraoperative pressure and outflow measurements with short-term surgical success and complications. Participants are recruited from surgeons affiliated with the Mount Sinai Health System and will receive standard surgical care with added intraoperative monitoring.
Who should consider this trial
Good fit: Adults (18 and older) undergoing cataract and/or glaucoma surgery at the Mount Sinai Health System who can provide informed consent are ideal candidates.
Not a fit: People under 18, pregnant women, those lacking decision-making capacity, prisoners, and patients treated outside Mount Sinai are excluded and would not receive direct benefit from participation.
Why it matters
Potential benefit: If successful, intraoperative pressure measurements could help surgeons predict which patients will achieve better IOP control and tailor postoperative management to reduce complications.
How similar studies have performed: Measuring ocular outflow and IOP has been studied before, but using an intraoperative disposable tonographic sensor to predict postoperative outcomes is relatively novel with limited published outcome data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Gautam Kamthan, MD
- Email: gautam.kamthan@mountsinai.org
- Phone: 212-979-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.