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Neovascularization Patterns in Corneal Graft Rejection

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01695655
Collaborator
(none)
44
Enrollment
1
Location
109
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    44 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Neovascularization Patterns in Corneal Graft Rejection
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    PKP

    Subjects undergoing penetrating keratoplasty

    Outcome Measures

    Primary Outcome Measures

    1. Corneal graft rejection [0 to 2 years after transplant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • scheduled for corneal transplant
    Exclusion Criteria:
    • previous corneal transplant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roni Shtein, Assistant Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01695655
    Other Study ID Numbers:
    • Neovasc-6281
    First Posted:
    Sep 28, 2012
    Last Update Posted:
    Mar 15, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Mar 15, 2017