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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044030
Receipt No. R000050278
Scientific Title Corneal Neurotization for treatment of neurotrophic keratopathy
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/24

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Basic information
Public title Corneal Neurotization for treatment of neurotrophic keratopathy
Acronym Corneal Neurotization for treatment of neurotrophic keratopathy
Scientific Title Corneal Neurotization for treatment of neurotrophic keratopathy
Scientific Title:Acronym Corneal Neurotization for treatment of neurotrophic keratopathy
Region
Japan

Condition
Condition Neurotrophic keratopathy
Classification by specialty
Ophthalmology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the efficacy of corneal neurotization for the treatment of neurotrophic keratopathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes corneal sensation
(preop to 2-year-postop)
Key secondary outcomes visual acuity

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Corneal neurotization
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
5 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with neurotrophic keratopathy due to reduced corneal sensation
Key exclusion criteria Those with uncontrolled diabetes and bad general conditions
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yamaguchi
Middle name
Last name Takefumi
Organization Tokyo Dental College
Division name Ophthalmology
Zip code 2728513
Address Sugano 5-11-13, Ichikawa, Chiba, JAPAN
TEL 0473220151
Email yamaguchit@tdc.ac.jp

Public contact
Name of contact person
1st name Yamaguchi
Middle name
Last name Takefumi
Organization Tokyo Dental College
Division name Ophthalmology
Zip code 2728513
Address Sugano 5-11-13, Ichikawa, Chiba, JAPAN
TEL 0473220151
Homepage URL
Email yamaguchit@tdc.ac.jp

Sponsor
Institute Tokyo Dental College
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Dental College
Address Sugano 5-11-13, Ichikawa, Chiba, JAPAN
Tel 0473220151
Email yamaguchit@tdc.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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 04 Month 19 Day
Date of IRB
2021 Year 04 Month 19 Day
Anticipated trial start date
2021 Year 04 Month 20 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 24 Day
Last modified on
2021 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050278

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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