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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01244776 |
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Date of registration:
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18/11/2010 |
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Primary sponsor: |
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Public title:
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Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
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Scientific title:
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Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01244776 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Liuhe Zhou |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Yongbo Lu |
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Address:
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Telephone:
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86-29-84776153 |
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Email:
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yongerbo@gmail.com |
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Affiliation:
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Name:
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Liuhe Zhou, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Tongren Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged between 18 and 75 yrs.
- Corneal ulcer.
- Informed consent.
Exclusion Criteria:
- Corneal perforation.
- Other ocular diseases.
- The presence of systemic connective tissue diseases
- Severe allergic constitution
- Pregnancy
- The presence of chronic disease, such as significant cardiovascular illness
- The patients who received clinical experiments for other medicine or medical devices
within 3 months prior to the transplantation.
- Any patient that is not suitable for recruitment, in the judgment of the
investigator.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Corneal Ulcer
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Intervention(s)
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Device: acellular corneal matrix
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Primary Outcome(s)
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Rejection evaluation
[Time Frame: 30 days following transplantation]
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Secondary Outcome(s)
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Corneal wound healing
[Time Frame: 90 days following transplantation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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