Neovascularization Patterns in Corneal Graft Rejection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
ClinicalTrials.gov Identifier:
NCT01695655
First received: September 26, 2012
Last updated: January 21, 2013
Last verified: January 2013
  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 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 2015
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695655

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

No publications provided

Responsible Party: Roni Shtein, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01695655     History of Changes
Other Study ID Numbers: Neovasc-6281
Study First Received: September 26, 2012
Last Updated: January 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014