Retrospective Analysis of Surgical Outcomes After Corneal... | NCT01547975

Studies
Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

NCT01547975

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Apr 3, 2012Estimated

Enrollment

1,000Actual

Phase

Not provided

Conditions

Corneal Transplantation

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Mar 4, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2012

Last Update Posted Date

Apr 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Hospital, Wei-Li Chen, MD, PhD, Assistant Professor, National Taiwan University Hospital, department of Ophthalmology., National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who received corneal transplantation within full chart records.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei-Li Chen, MD,PhD	NTUH	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital, department of Ophthalmology		Taipei	Taiwan	100	Taiwan