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
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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 November 27, 2014
||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