NCT00875043

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
Last Updated

October 14, 2016

Status Verified

April 1, 2009

Enrollment Period

3 months

First QC Date

April 1, 2009

Last Update Submit

October 13, 2016

Conditions

Keywords

ischemic optic neuropathycortical blindness

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

BlindnessOptic Neuropathy, IschemicBlindness, Cortical

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOptic Nerve DiseasesCranial Nerve DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Geordie P. Grant, MD

    University of Medicine & Dentistry of New Jersey

    PRINCIPAL INVESTIGATOR

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

Locations