Intra Ocular Pressure During Robotic Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00369057
First received: August 25, 2006
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

Our goal is to study the relationship between intraocular pressure during robotic prostatectomy surgery and visual deficiencies/vision 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 disturbance.If our hypothesis that intraocular pressure is increased in these patients is confirmed, future studies will assess therapeutic modalities to maintain the IOP near baseline.


Condition Phase
Visual Acuity
Visual Disturbance
Intraocular Pressure
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra Ocular Pressure During Robotic Prostatectomy

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Enrollment: 15
Study Start Date: February 2006
Study Completion Date: February 2008
Detailed Description:

The frequency of post-operative permanent vision loss has been recently estimated to be 1:61,0001,2 , 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 1:125,0003 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 (laparoscopy).5

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 outcome.6

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult males aged 18 or older, undergoing robotic prostatectomy at NewYork Presbyterian Hospital with no pre-existing eye conditions.

Criteria

Inclusion Criteria:

  • Male, aged 18 or older
  • Scheduled for Robotic Prostatectomy Surgery
  • ASA Classification of I, II, or III
  • Good comprehension of written and spoken english.

Exclusion Criteria:

  • Allergy to Tetracaine or related anesthetics
  • Glaucoma
  • Asthma
  • History of heart electrical problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369057

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Patricia Fogarty-Mack, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00369057     History of Changes
Other Study ID Numbers: 0510008190
Study First Received: August 25, 2006
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Intraocular pressure
Prostatectomy
Robotic
Glaucoma
Carbon dioxide

ClinicalTrials.gov processed this record on September 18, 2014