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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01547975
Other study ID # 201004004R
Secondary ID
Status Completed
Phase N/A
First received March 4, 2012
Last updated April 1, 2012
Start date April 2010
Est. completion date March 2012

Study information

Verified date March 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of HealthTaiwan: Institutional Review BoardTaiwan: National Bureau of Controlled Drugs
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 90 Years
Eligibility 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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital, department of Ophthalmology Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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