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Cornea Preservation Time Study

NCT01537393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1174

Last updated 2018-04-23

Study results available
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Summary

The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.

Conditions

  • Cornea Preservation Time
  • Endothelial Keratoplasty
  • Transplant Success
  • Endothelial Cell Density

Interventions

BIOLOGICAL

Cornea tissue transplant

Cornea tissue preserved 0 to 7 days

BIOLOGICAL

Cornea tissue transplant

Cornea tissue preserved 8 to 14 days.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Jonathan Lass, MD · Case Western Reserve University

  • Allison Ayala, MS · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-16
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537393 on ClinicalTrials.gov