A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
This study has been terminated.
(Difficulty in enrolling subjects.)
Information provided by (Responsible Party):
Roy Soto, MD, William Beaumont Hospitals
First received: March 16, 2012
Last updated: July 16, 2014
Last verified: July 2014
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.
Intraocular Pressure Disorder
||Observational Model: Cohort
Time Perspective: Prospective
||A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine rate of rise of IOP during steep Trendelenburg positioning [ Time Frame: 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. ] [ Designated as safety issue: No ]
- To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects. [ Time Frame: 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. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres)
BMI less than or equal to 30 kg/m2
Eye pressure will be measured at protocol specified intervals.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- Age 18-70
- ASA (American Society of Anesthesiologists) physical status classification I, II, or III
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737645
|William Beaumont Hospital
|Royal Oak, Michigan, United States, 48073 |
William Beaumont Hospitals
||Roy G Soto, MD
||William Beaumont Hospitals
No publications provided
ClinicalTrials.gov processed this record on February 26, 2015
||Roy Soto, MD, Principal Investigator, William Beaumont Hospitals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 16, 2012
||July 16, 2014
||United States: Food and Drug Administration