Neovascularization Patterns in Corneal Graft Rejection

NCT ID: NCT01695655

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Corneal Transplant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PKP

Subjects undergoing penetrating keratoplasty

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• scheduled for corneal transplant

Exclusion Criteria

• previous corneal transplant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Roni Shtein

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roni Shtein, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University Of Michigam Kellogg Eye Center

Locations

Kellogg Eye Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Neovasc-6281

Identifier Type: -

Identifier Source: org_study_id