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Main
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Note: This record shows only 22 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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000002948 |
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Date of registration:
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29/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency
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Scientific title:
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Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency - Cultivated corneal epithelial sheet transplantation |
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Date of first enrolment:
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2013/04/01 |
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Target sample size:
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5 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003586 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shigeto Shimmura |
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Address:
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35 Shinanomachi, Shinjuku, Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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shige@z8.keio.jp |
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Affiliation:
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Keio University School of Medicine Department of Ophthalmology |
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Name:
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Kazuo Tsubota |
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Address:
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35 Shinanomachi, Shinjuku, Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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tsubota@z3.keio.jp |
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Affiliation:
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Keio University School of Medicine Department of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) Corneal disease of unknown etiology (2) Active infection (3) Glaucoma (4) Diabetes mellitis with poor BS control (5) Hypersensitivity to steroids or immunosuppressants (6) Patients planned for other intraocular surgery (7) Pregnancy
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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a) Steven's Johnson Syndrome b) Ocular cicatricial pemphigoid c) Chemical/ Thermal Burns of the Cornea d) Gelatinous Drop Like Dystrophy e) Salzmann Corneal Degeneration f) Congenital Aniridia
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Intervention(s)
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Corneal epithelial sheet transplantation Cultivated eptihealial sheet transplantation will be perfored in the surgical department of Keio University Hospital. Simultaneous lamellar keratoplasty will be allowed. Surgical procedure involves removal of all pannus and abnormal epithelial tissue, the use of 0.04% mitomycin C to prevent fibrosis, and transplantation of the cultivated sheet.
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Primary Outcome(s)
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Improved visual acuity
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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