A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients

William Beaumont Hospitals1 site in 1 country4 target enrollmentAugust 2012

ConditionsIntraocular Pressure Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intraocular Pressure Disorder
Sponsor: William Beaumont Hospitals
Enrollment: 4
Locations: 1
Primary Endpoint: To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.

Detailed Description

Eye pressure will be measured at protocol specified intervals.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

July 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

William Beaumont Hospitals

Responsible Party

Principal Investigator

Roy Soto, MD

Principal Investigator

William Beaumont Hospitals

Eligibility Criteria

Inclusion Criteria

•Subjects undergoing prolonged procedures (scheduled \>3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
•Morbidly obese subjects: BMI ≥ 35 kg/m2
•Thin subjects: BMI ≤ 30 kg/m2
•ASA (American Society of Anesthesiologists) physical status classification I, II, or III

Exclusion Criteria

•Known history of glaucoma
•Note:if initial IOP is noted to be \>21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
•Recent use of IOP lowering topical ophthalmic agents
•Allergy to latex or proparacaine hydrochloride ophthalmic solution
•Patients with active corneal epithelial defects or history of recurrent corneal erosion
•Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology)
•History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
•Any eye surgery within prior 1 month
•Known pregnancy
•Cognitive impairment

Outcomes

Primary Outcomes

To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.

Time Frame: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.

Secondary Outcomes

To determine rate of rise of IOP during steep Trendelenburg positioning(The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.)
To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.(The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.)