Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01695655
Other study ID # Neovasc-6281
Secondary ID
Status Completed
Phase N/A
First received September 26, 2012
Last updated March 13, 2017
Start date November 2007
Est. completion date December 2016

Study information

Verified date March 2017
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- scheduled for corneal transplant

Exclusion Criteria:

- previous corneal transplant

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Kellogg Eye Center Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Corneal graft rejection 0 to 2 years after transplant
See also
  Status Clinical Trial Phase
Completed NCT04521140 - Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery Phase 4
Completed NCT03685851 - Post Operative Visual Acuity for DSAEK and UT-DSAEK