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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.)
Sponsor:
Information provided by (Responsible Party):
Roy Soto, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01737645
First received: March 16, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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
Intraocular Pressure Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

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 ]

Enrollment: 4
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Eye pressure will be measured at protocol specified intervals.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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

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
  More Information

No publications provided

Responsible Party: Roy Soto, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01737645     History of Changes
Other Study ID Numbers: 2011-273
Study First Received: March 16, 2012
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014