UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044030 |
|---|---|
| Receipt number | 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 22:51:51 |
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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
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
yamaguchit@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050278
