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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021423
Receipt No. 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 2020/09/25

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Basic information
Public title Safety and effectiveness of corneal neurotization from the supratrochlear nerve with nerve graft
Acronym Corneal neurotization
Scientific Title Safety and effectiveness of corneal neurotization from the supratrochlear nerve with nerve graft
Scientific Title:Acronym Corneal neurotization
Region
Japan

Condition
Condition trigeminal neurotrophic keratopathy
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and safety of the corneal neurotization from the contralateral supratrochlear nerve with nerve graft
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes corneal sensibility test at post op. 6 month, 12month, 24month, 36month
Key secondary outcomes A Schirmer's test at post op. 6 month, 12month, 24month, 36month

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cable graft is placed between contralateral supratrochlear nerve and pericorneal tissue
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria patient with unilateral facial
palsy and anesthetic corneal keratopathy
Key exclusion criteria 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
Target sample size 1

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Tachi
Organization Graduate School of
Medicine, Tohoku University
Division name Department of Plastic and Reconstructive Surgery
Zip code 9808574
Address 2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL 0227177748
Email tachi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshimichi
Middle name
Last name Imai
Organization Graduate School of Medicine
Division name Department of Plastic and Reconstructive Surgery
Zip code 9808574
Address 2-1, Seiryo-machi, Aoba-ku, Sendai,
TEL 0227177748
Homepage URL
Email yo-imai@med.tohoku.ac.jp

Sponsor
Institute Graduate School of
Medicine, Tohoku University
Institute
Department

Funding Source
Organization Management Expenses Grants
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization ethical boad of Tohoku University hospital
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
Tel 0227177711
Email rinri-esct@proj.med.tohoku.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 Day

Related information
URL releasing protocol https://www.rinri.med.tohoku.ac.jp/esct/Apply/project.aspx?PROJECT_ID=2104
Publication of results Partially published

Result
URL related to results and publications http://www.congre.co.jp/cornea2018/
Number of participants that the trial has enrolled 1
Results
Surgery was peformed on Apr. 4, 2016. Patient is now folloed up at out patient clinic.The sensation of cornea has improved.  
Results date posted
2019 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
facial nerve paralysis with trigeminal nerve palsy
Participant flow
treated 
Adverse events
nothing
Outcome measures
sensation of the cornea
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 03 Month 25 Day
Date of IRB
2016 Year 03 Month 30 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
2019 Year 04 Month 15 Day
Date trial data considered complete
2019 Year 04 Month 26 Day
Date analysis concluded
2019 Year 05 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 10 Day
Last modified on
2020 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024711

Research Plan
Registered date File name
2016/04/21 160330  sop2_3_protocol_temp.doc

Research case data specifications
Registered date File name
2016/04/21 160309 症例記録.doc

Research case data
Registered date File name


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