Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369057
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2006-08-25
Brief Title:
Intra Ocular Pressure During Robotic Prostatectomy
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Intra Ocular Pressure During Robotic Prostatectomy
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our goal is to study the relationship between intraocular pressure during robotic prostatectomy surgery and visual deficienciesvision loss after surgery We believe the risk of vision loss from this surgery to be due to positioning during the operation as well as abdominal carbon dioxide insufflation As robotic procedures are gaining in popularity we should determine whether they are subjecting this patient population and perhaps more likely the patient with a preoperative diagnosis of glaucoma to an increased likelihood of postoperative visual disturbanceIf our hypothesis that intraocular pressure is increased in these patients is confirmed future studies will assess therapeutic modalities to maintain the IOP near baseline
Detailed Description:
The frequency of post-operative permanent vision loss has been recently estimated to be 16100012 although the majority of these cases involve surgical trauma to the eye or brain Prolonged vision loss not attributable to direct trauma has been estimated to occur with a frequency of approximately 11250003 and has been given a broad classification termed ischemic optic neuropathy This rare but catastrophic outcome has most commonly been associated with operations performed under circumstances in which there may be increased intraocular pressure IOP either due to positioning4 or due to insufflation of the abdomen with carbon dioxide laparoscopy5
There are two factors predisposing the robotic prostatectomy patient to an increase in IOP step head-down Trendelenburg position and abdominal carbon dioxide CO2 insufflation The Trendelenburg position will increase central venous pressure within the thorax which may reduce the drainage of blood flow from the head thus increasing IOP The CO2 insufflation may increase IOP via two mechanisms First by increasing intra-abdominal pressure there is a further increase in intrathoracic pressure Secondly insufflation the CO2 may increase the carbon dioxide content of the blood to which the brain reacts by vasodilating and increasing blood volume Thus while flow into the eye is increased flow out of the eye is decreased leading to an increase in pressure inside the eye which eventually may reduce the inflow enough to cause retinal or optic nerve ischemia
Because the pressure within the eye is an important factor in determining the blood flow to the eye prevention of a dramatic increase in IOP may make patients less vulnerable to peri-operative ischemic optic neuropathy and vision loss Because permanent vision loss is such a rare event after surgery this study will measure more subtle and most likely temporary vision changes subjective blurriness visual field deficits decreased acuity which occur more frequently and are thus a more easily measured outcome6
As robotic procedures are gaining in popularity we should determine whether they are subjecting this patient population and perhaps more likely the patient with a preoperative diagnosis of glaucoma to an increased likelihood of postoperative visual disturbance
There are two factors predisposing the robotic prostatectomy patient to an increase in IOP step head-down Trendelenburg position and abdominal carbon dioxide CO2 insufflation The Trendelenburg position will increase central venous pressure within the thorax which may reduce the drainage of blood flow from the head thus increasing IOP The CO2 insufflation may increase IOP via two mechanisms First by increasing intra-abdominal pressure there is a further increase in intrathoracic pressure Secondly insufflation the CO2 may increase the carbon dioxide content of the blood to which the brain reacts by vasodilating and increasing blood volume Thus while flow into the eye is increased flow out of the eye is decreased leading to an increase in pressure inside the eye which eventually may reduce the inflow enough to cause retinal or optic nerve ischemia
Because the pressure within the eye is an important factor in determining the blood flow to the eye prevention of a dramatic increase in IOP may make patients less vulnerable to peri-operative ischemic optic neuropathy and vision loss Because permanent vision loss is such a rare event after surgery this study will measure more subtle and most likely temporary vision changes subjective blurriness visual field deficits decreased acuity which occur more frequently and are thus a more easily measured outcome6
As robotic procedures are gaining in popularity we should determine whether they are subjecting this patient population and perhaps more likely the patient with a preoperative diagnosis of glaucoma to an increased likelihood of postoperative visual disturbance
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