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

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ClinicalTrials.gov Identifier: NCT01737645
Recruitment Status : Terminated (Difficulty in enrolling subjects.)
First Posted : November 29, 2012
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Roy Soto, MD, 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.

Condition or disease
Intraocular Pressure Disorder

Detailed Description:
Eye pressure will be measured at protocol specified intervals.

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Group/Cohort
obese patients
BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres)
Thin patients
BMI less than or equal to 30 kg/m2



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737645


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Roy G Soto, MD William Beaumont Hospitals

Responsible Party: Roy Soto, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01737645     History of Changes
Other Study ID Numbers: 2011-273
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014