UMIN-CTR Clinical Trial

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

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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 or person

Institute

Graduate School of
Medicine, Tohoku University

Institute

Department

Personal name



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

Completed

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

2021 Year 03 Month 26 Day



Link to view the page

Value
https://center6.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