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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Eye pressure will be measured at protocol specified intervals.

Conditions

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Intraocular Pressure Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Thin patients

BMI less than or equal to 30 kg/m2

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No