Neovascularization Patterns in Corneal Graft Rejection

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Roni Shtein, University of Michigan Identifier:
First received: September 26, 2012
Last updated: January 26, 2016
Last verified: January 2016

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.

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 University of Michigan:

Primary Outcome Measures:
  • Corneal graft rejection [ Time Frame: 0 to 2 years after transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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.

Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with indications of corneal transplant

Inclusion Criteria:

  • scheduled for corneal transplant

Exclusion Criteria:

  • previous corneal transplant
  Contacts and Locations
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Please refer to this study by its identifier: NCT01695655

United States, Michigan
Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Roni Shtein, Assistant Professor, University of Michigan Identifier: NCT01695655     History of Changes
Other Study ID Numbers: Neovasc-6281 
Study First Received: September 26, 2012
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neovascularization, Pathologic
Pathologic Processes processed this record on May 25, 2016