Clinical trial NCT01737645: A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
Official title: A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intraocular Pressure Disorder
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Subjects undergoing prolonged procedures expected to be in steep Trendelenburg position. Procedure must be scheduled for \> 3 hours, eg. robotic prostatectomy, hysterectomy, and cystectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: To determine rate of rise of IOP during steep Trendelenburg positioning
timeFrame: 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.
measure: To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.
timeFrame: 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.
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Roy G Soto, MD
role: PRINCIPAL_INVESTIGATOR
References: