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

Intraocular Pressure Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737645
• Other study ID #: 2011-273
• Status: Terminated
• Phase: N/A
• First received: March 16, 2012
• Last updated: July 16, 2014
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Eye pressure will be measured at protocol specified intervals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraocular Pressure Disorder

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No