Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611670
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Outcomes of High Vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of High Vs Physiological Intraocular Pressure During Cataract Surgery Using ACTIVE SENTRY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVESENTRY
Brief Summary:
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts Irrigation is an essential component of the surgery Fluid is constantly circulated to help regulate temperature as heat is generated with ultrasound energy to minimize tissue trauma and to create an intraocular pressure IOP sufficient to keep the anterior chamber AC stable In parallel aspiration brings the components of the cataract closer to the surgical instrument A balance between irrigation and aspiration during surgery is essential to maintain stability in the AC However an ideal flow rate which influences IOP during surgery is yet to be determined Most recent studies with Centurion Active Sentry show that there is similar efficiency between higher and lower IOP settings Traditionally high-flow rates have been used in advanced cataracts and are believed to make space in the AC However they are known to create fluid turbulence and are associated with risks of tissue damage including cell loss in one of the corneas layers High IOP during surgery has also been shown to cause damage to the optic nerve as well as to the retina Distorting and stretching the AC during phacoemulsification have also been associated with increased pain experienced by the patient Comfort can be achieved by lowering pressure levels Low-flow rates have a better safety profile reduce IOP and pressure fluctuations while offering equal efficiency including comparable surgical time Using central corneal thickness CCT as an indicator of corneal trauma it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively as opposed to patients in the high-flow rates As less fluid turbulence is created with low-flow rates there is decreased risk of fragment contact with the corneas inner surface thus reducing cell loss Alcon Laboratories Inc developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation It allows rapid feedback to maintain a stable AC Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels
Detailed Description:
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts The surgery has known many improvements across time and continues to do so Irrigation is an essential component of the surgery Fluid is constantly being circulated to help regulate temperature as heat is generated with the use of ultrasound energy to minimize tissue trauma and to create an intraocular pressure sufficient to keep the anterior chamber stable In parallel aspiration brings the components of the cataract closer to the surgical instrument A balance between irrigation and aspiration during surgery is essential to maintain stability in the anterior chamber However an ideal flow rate which influences intraocular pressure IOP during surgery is yet to be determined Most recent studies with Centurion Active Sentry maintaining vacuum and aspiration rates the same show that there is similar efficiency between higher and lower IOP settings Traditionally high-flow rates have been used in advanced cataracts and are believed to increase the space in the anterior chamber However they are known to create fluid turbulence and are associated with risks of tissue damage including cell loss in the endothelial layer of the cornea High intra-ocular pressure during surgery has also been shown to cause damage to the optic nerve as well as to the retina Distorting and stretching the anterior chamber during phacoemulsification have also been associated with increased pain experienced by the patient Comfort can be achieved by lowering pressure levels Low-flow rates have a better safety profile reduce IOP and pressure fluctuations while offering equal efficiency including comparable surgical time Using central corneal thickness CCT as an indicator of corneal trauma it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively while patients in the high-flow rates show signs of corneal damage as well as greater anterior segment inflammation As less fluid turbulence is created with low-flow rates there is decreased risk of fragment contact with the corneas inner surface thus reducing cell loss Alcon Laboratories Inc developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation It allows rapid feedback to maintain a stable anterior chamber Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None