UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033057
Receipt No. R000037681
Scientific Title To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty)
Date of disclosure of the study information 2018/06/20
Last modified on 2019/07/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty)
Acronym To investigate of corneal transplantation using imported cornea
Scientific Title To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty)
Scientific Title:Acronym To investigate of corneal transplantation using imported cornea
Region
Japan

Condition
Condition Bullous keratopathy,Corneal opacity,corneal perforation,keratoconus etc
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluation on safety of keratoplasty using imported cornea
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analysis of the shape of A cornea using anterior segment optical coherence tomography of 1 month after surgery
Key secondary outcomes endothelial cell density 1 month after surgery
Perioperative bacteriological inspection

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 keratoplasty
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
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria The patient who needs the keratoplasty including bullous keratopathy, corneal opacity, corneal perforation, keratoconus and the other
The patient that visual acuity will be expected to recover by keratoplasty
The patient that it was understood enough after having received enough explanation, and a document agreement by the free will of a patient was provided.
Key exclusion criteria The patient who can expect recovery of the visual acuity by a therapeutic method except the keratoplasty.
The patient have a disease that treatment is more necessary than doing keratoplasty.
The patient won't gain the benefit for ophthalmic operation by other diseases.
The patient that during the pregnancy or the pregnancy became clear.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Mastuzawa
Organization Kawasaki Municipal Tama hospital
Division name Ophthalmology
Zip code 2148525
Address 1-30-37, Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL 044-933-8111
Email matuzo3a@marianna-u.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Mastuzawa
Organization Kawasaki Municipal Tama hospital
Division name Ophthalmology
Zip code 2148525
Address 1-30-37, Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL 0449338111
Homepage URL
Email matuzo3a@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization Kawasaki Municipal Tama hospital
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 St.Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel 0449778111
Email matuzo3a@marianna-u.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
2018 Year 06 Month 20 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
2015 Year 09 Month 24 Day
Date of IRB
2015 Year 09 Month 24 Day
Anticipated trial start date
2015 Year 09 Month 24 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 19 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.