Corneal TransplantationNCT01547975
Retrospective Analysis of Surgical Outcomes After Corneal Transplantation
An observational study of Corneal Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Transplantation
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patients who received corneal transplantation within full chart records.
Who may be able to join
- The patients who received corneal transplantation within full chart records
Who cannot join
- The patients have cognitive Impairment.
- No detail or unclear ophthalmologic record.
- Patients or their legal representative have no willing to accept this tracing study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 100
About this study
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.
Read the 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.
- Conditions
- Corneal Transplantation
- Keywords
- surgical outcomes after corneal transplantation, Retrospective analysis, corneal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Wei-Li Chen, MD,PhD, Study chair, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547975
- Sponsor's protocol ID
- 201004004R
- Status last verified
- Mar 2012
- First submitted
- 4 Mar 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Surgical Outcomes After Corneal Transplantation
- ClinicalTrials.gov ID
- NCT01547975
- Acronym / sponsor ID
- 201004004R
- Conditions
- Corneal Transplantation
- Keywords
- surgical outcomes after corneal transplantation, Retrospective analysis, corneal transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who received corneal transplantation within full chart records.
Key inclusion criteria (1 listed)
- The patients who received corneal transplantation within full chart records
Key exclusion criteria (3 listed)
- The patients have cognitive Impairment.
- No detail or unclear ophthalmologic record.
- Patients or their legal representative have no willing to accept this tracing study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Chen, MD,PhD study chair
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2012.