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OpenTrials
Completed

NCT Number: NCT00369057

Intra Ocular Pressure During Robotic Prostatectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
Aug 29, 2006
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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