Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01547975
First received: March 4, 2012
Last updated: April 1, 2012
Last verified: March 2012
  Purpose

Currently, no demographic and surgical results comparing different donor cornea sources were available in Taiwan. National Taiwan University Hospital (NTUH), as one of the largest tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care for patients receiving corneal transplantation. With detailed medical record done of these patients during care in the ward and out-patient clinic, the investigators are competence for this meaningful program.


Condition
Corneal Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

Further study details as provided by National Taiwan University Hospital:

Enrollment: 1000
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

An insufficient donor supply is a worldwide problem in organ transplantation. Even with corneal transplantations, the most widely performed transplantation, shortages and imbalances in donor supply is a global concern. In National Taiwan University Hospital (NTUH), the investigators performed over one hundred of corneal transplantations every year and the majority of donor corneas were from the eye bank in United States. Previous literature showed satisfactory results in corneal transplantation using foreign donor corneas compared with domestic corneas. However longer preservation time had associated with a statistically significant increased risk of persistence of the postoperative epithelial defect. On the other hand, longer storage times may allow better outcomes in high-risk grafts because of the depletion of donor T cells from the donor cornea into the storage media.

Currently, no demographic and surgical results comparing different donor cornea sources were available in Taiwan. NTUH, as one of the largest tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care for patients receiving corneal transplantation. With detailed medical record done of these patients during care in the ward and out-patient clinic, the investigators are competence for this meaningful program.

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The patients who received corneal transplantation within full chart records.

Criteria

Inclusion Criteria:

  • The patients who received corneal transplantation within full chart records

Exclusion Criteria:

  • The patients have cognitive Impairment.
  • No detail or unclear ophthalmologic record.
  • Patients or their legal representative have no willing to accept this tracing study.
  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: NCT01547975

Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Wei-Li Chen, MD,PhD NTUH
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Wei-Li Chen, MD, PhD, Assistant Professor, National Taiwan University Hospital, department of Ophthalmology.
ClinicalTrials.gov Identifier: NCT01547975     History of Changes
Other Study ID Numbers: 201004004R
Study First Received: March 4, 2012
Last Updated: April 1, 2012
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs

Keywords provided by National Taiwan University Hospital:
surgical outcomes after corneal transplantation
Retrospective analysis
corneal transplantation

ClinicalTrials.gov processed this record on August 20, 2014