NCT01695655

Brief Summary

Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. . This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 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

November 1, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

8.1 years

First QC Date

September 26, 2012

Last Update Submit

March 13, 2017

Conditions

Corneal Transplant

Outcome Measures

Primary Outcomes (1)

  • Corneal graft rejection

    0 to 2 years after transplant

Study Arms (1)

PKP

Subjects undergoing penetrating keratoplasty

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects with indications of corneal transplant

You may qualify if:

  • scheduled for corneal transplant

You may not qualify if:

  • previous corneal transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Study Officials

  • Roni Shtein, MD, MS

    University Of Michigam Kellogg Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

November 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 15, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)