Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning

NCT01261871 | Completed DMC

• 1 other identifier: NMCSD.2008.0045
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure pressures within the eye (during surgery to remove the prostate or abdominopelvic masses) as the body position required for these laparoscopic procedures has been associated with increases in pressure within the eye.

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Effect of radical prostatectomy technique on intraocular pressure.

  30 days post surgical procedure.

Study Arms (1)

Robotic laparoscopic prostatectomy

Patients who are undergoing primary surgical treatment for a diagnosis of prostate operatively will be enrolled. IOP will be measured throughout the case to assess for change. The various techniques employed for a radical prostatectomy will be compared. Patients undergoing RRP (open surgery) will act as controls. Those undergoing LRP (minimally invasive surgery) will be compared with the control group to assess for differences in IOP that may result from the different approaches. three arms will be used for the comparison: open, laparoscopic intraperitoneal approach), and laparoscopic (extraperitoneal approach).

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing primary radical prostatectomy for the diagnosis of prostate cancer at Naval Medical Center San Diego.

You may qualify if:

• Age ≥ 18 years
• Patients choosing to undergo surgical treatment for prostate cancer

You may not qualify if:

• Prior treatment of prostate cancer by any means
• History of glaucoma, macular degeneration, or diabetic retinopathy
• History of eye trauma/injury
• History of non-refractive eye surgery
• Allergy to topical anesthetic (this will be used during the eye exam)

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

United States Naval Medical Center

San Diego, California, 92134-5000, United States

Location

MeSH Terms

Conditions

Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Brian K Auge, M.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)