Corneal TransplantNCT01695655
Neovascularization Patterns in Corneal Graft Rejection
An observational study of Corneal Transplant, run by University of Michigan at 1 site in United States.
Trial summary
Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. . This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Corneal Transplant
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2016
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with indications of corneal transplant
Who may be able to join
- scheduled for corneal transplant
Who cannot join
- previous corneal transplant
Trial locations and contacts
1 site in 1 country.
About this study
Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. .
This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.
Read the detailed description
The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.
- Conditions
- Corneal Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PKP | Subjects undergoing penetrating keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal graft rejection
Measured: 0 to 2 years after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startNov 2007
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roni Shtein, University of Michigan
- Investigators
- Roni Shtein, MD, MS, Principal investigator, University Of Michigam Kellogg Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695655
- Sponsor's protocol ID
- Neovasc-6281
- Status last verified
- Mar 2017
- First submitted
- 26 Sep 2012
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neovascularization Patterns in Corneal Graft Rejection
- ClinicalTrials.gov ID
- NCT01695655
- Acronym / sponsor ID
- Neovasc-6281
- Conditions
- Corneal Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 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.
Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. .
This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.
Detailed description
The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PKP | – | –Subjects undergoing penetrating keratoplasty |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with indications of corneal transplant
Key inclusion criteria (1 listed)
- scheduled for corneal transplant
Key exclusion criteria (1 listed)
- previous corneal transplant
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
Corneal graft rejection
Time frame: 0 to 2 years after transplant
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 15 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Roni Shtein, MD, MS principal investigator
University Of Michigam Kellogg Eye Center
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 Transplant, run by University of Michigan at 1 site in United States.
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 1 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 15 Mar 2017. 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 United States. 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.
What does the primary outcome measure?
Corneal graft rejection (time frame: 0 to 2 years after transplant). It is what the study was designed to measure, not a finding.
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 15 Mar 2017.