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Neovascularization Patterns in Corneal Graft Rejection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695655
First Posted: September 28, 2012
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
  Purpose

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.


Condition
Corneal Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neovascularization Patterns in Corneal Graft Rejection

Further study details as provided by Roni Shtein, University of Michigan:

Primary Outcome Measures:
  • Corneal graft rejection [ Time Frame: 0 to 2 years after transplant ]

Enrollment: 44
Study Start Date: November 2007
Study Completion Date: December 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
PKP
Subjects undergoing penetrating keratoplasty

Detailed Description:
The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with indications of corneal transplant
Criteria

Inclusion Criteria:

  • scheduled for corneal transplant

Exclusion Criteria:

  • previous corneal transplant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695655


Locations
United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roni Shtein, MD, MS University Of Michigam Kellogg Eye Center
  More Information

Responsible Party: Roni Shtein, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01695655     History of Changes
Other Study ID Numbers: Neovasc-6281
First Submitted: September 26, 2012
First Posted: September 28, 2012
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neovascularization, Pathologic
Metaplasia
Pathologic Processes