UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000037681