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

Sponsor
William Beaumont Hospitals (Other)
Overall Status
Terminated
CT.gov ID
NCT01737645
Collaborator
(none)
4
Enrollment
1
Location
23
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Detailed Description

    Eye pressure will be measured at protocol specified intervals.

    Study Design

    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 :
    Aug 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    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. [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 [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. [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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roy Soto, MD, Principal Investigator, William Beaumont Hospitals
    ClinicalTrials.gov Identifier:
    NCT01737645
    Other Study ID Numbers:
    • 2011-273
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Jul 17, 2014
    Last Verified:
    Jul 1, 2014

    Study Results

    No Results Posted as of Jul 17, 2014