Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract | disposable Deltran I pressure sensor for Cataract |
| |
| Glaucoma | disposable Deltran I pressure sensor for Glaucoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable Deltran I pressure sensor | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intraoperative and postoperative complications. | Percentage rate of intraoperative and postoperative complications. | 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gautam Kamthan, MD | Contact | 212-979-4000 | gautam.kamthan@mountsinai.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye and Ear Infirmary of Mount Sinai | Recruiting | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26949939 | Background | 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. |
Not provided
Not provided
Undecided at this time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
Not provided
Not provided