Unique ID issued by UMIN | UMIN000021423 |
---|---|
Receipt number | R000024711 |
Scientific Title | Safety and effectiveness of corneal neurotization from the supratrochlear nerve with nerve graft |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2021/03/26 17:31:25 |
Safety and effectiveness of corneal neurotization from the supratrochlear nerve with nerve graft
Corneal neurotization
Safety and effectiveness of corneal neurotization from the supratrochlear nerve with nerve graft
Corneal neurotization
Japan |
trigeminal neurotrophic keratopathy
Plastic surgery |
Others
NO
To evaluate effectiveness and safety of the corneal neurotization from the contralateral supratrochlear nerve with nerve graft
Efficacy
Exploratory
Phase II
corneal sensibility test at post op. 6 month, 12month, 24month, 36month
A Schirmer's test at post op. 6 month, 12month, 24month, 36month
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Cable graft is placed between contralateral supratrochlear nerve and pericorneal tissue
20 | years-old | <= |
80 | years-old | > |
Male and Female
patient with unilateral facial
palsy and anesthetic corneal keratopathy
1, active infection with corneal ulcer
2,severe cardiac failure, major pulmonary dysfunction
3, patients who cannot be followed or denied to be followed up
3, pregnant patients
4, patient who is attending other experimental protocol
1
1st name | Masahiro |
Middle name | |
Last name | Tachi |
Graduate School of
Medicine, Tohoku University
Department of Plastic and Reconstructive Surgery
9808574
2-1, Seiryo-machi, Aoba-ku, Sendai,
0227177748
tachi@med.tohoku.ac.jp
1st name | Yoshimichi |
Middle name | |
Last name | Imai |
Graduate School of Medicine
Department of Plastic and Reconstructive Surgery
9808574
2-1, Seiryo-machi, Aoba-ku, Sendai,
0227177748
yo-imai@med.tohoku.ac.jp
Graduate School of
Medicine, Tohoku University
Management Expenses Grants
Self funding
ethical boad of Tohoku University hospital
1-1, Seiryo-machi, Aoba-ku, Sendai
0227177711
rinri-esct@proj.med.tohoku.ac.jp
NO
東北大学病院
2016 | Year | 04 | Month | 01 | Day |
https://www.rinri.med.tohoku.ac.jp/esct/Apply/project.aspx?PROJECT_ID=2104
Partially published
http://www.congre.co.jp/cornea2018/
1
Surgery was peformed on Apr. 4, 2016. Patient is now folloed up at out patient clinic.The sensation of cornea has improved.
2019 | Year | 04 | Month | 15 | Day |
facial nerve paralysis with trigeminal nerve palsy
treated
nothing
sensation of the cornea
Completed
2016 | Year | 03 | Month | 25 | Day |
2016 | Year | 03 | Month | 30 | Day |
2016 | Year | 04 | Month | 01 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 04 | Month | 15 | Day |
2019 | Year | 04 | Month | 26 | Day |
2019 | Year | 05 | Month | 15 | Day |
2016 | Year | 03 | Month | 10 | Day |
2021 | Year | 03 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024711
Research Plan | |
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Registered date | File name |
2016/04/21 | 160330 sop2_3_protocol_temp.doc |
Research case data specifications | |
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Registered date | File name |
2016/04/21 | 160309 症例記録.doc |
Research case data | |
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Registered date | File name |