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

Terminated

• Conditions: Intraocular Pressure Disorder

• Registration Number: NCT01737645
• Lead Sponsor: William Beaumont Hospitals

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.

Study Timeline

• Study First Submitted: 2012-03-16
• Study Start: 2012-08
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Subjects undergoing prolonged procedures (scheduled >3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
2. Morbidly obese subjects: BMI ≥ 35 kg/m2
3. Thin subjects: BMI ≤ 30 kg/m2
4. Age 18-70
5. ASA (American Society of Anesthesiologists) physical status classification I, II, or III

Exclusion Criteria

1. Known history of glaucoma
2. 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.
3. Recent use of IOP lowering topical ophthalmic agents
4. Allergy to latex or proparacaine hydrochloride ophthalmic solution
5. Patients with active corneal epithelial defects or history of recurrent corneal erosion
6. 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)
7. History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
8. Any eye surgery within prior 1 month
9. Known pregnancy
10. Cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States