Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours
A Pilot Study to Determine the Effect on Intraocular Pressure, Optic Nerve Imaging and Other Markers of Venous Congestion of Volunteer Subjects in the Prone Position for a Period of Five Hours
1 other identifier
observational
10
1 country
1
Brief Summary
The purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedOctober 14, 2016
April 1, 2009
3 months
April 1, 2009
October 13, 2016
Conditions
Keywords
Study Arms (2)
1. flat Jackson table
All measurements previously described will be done with the patient in the prone postion and Jackson table flat.
2. Elevated Jackson tablet
All measurements previously described will be performed with subjects placed prone on the elevated Jackson table.
Eligibility Criteria
Healthy volunteers
You may qualify if:
- subjects willing to consent
You may not qualify if:
- individuals unable to tolerate prone position for 5 hours
- individuals unable to tolerate contact lens placement
- females who are pregnant
- individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1%
- individuals who are unable to have repeated mesaurements of intaocular pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMDNJ/University Hospital
Newark, New Jersey, 07101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geordie P. Grant, MD
University of Medicine & Dentistry of New Jersey
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 3, 2009
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
October 14, 2016
Record last verified: 2009-04
Data Sharing
- IPD Sharing
- Will not share