Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

Corneal Transplantation Clinical Trial

Official title:

Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547975
• Other study ID #: 201004004R
• 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

• Corneal Transplantation

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,