UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of corneal transplatation
Acronym	Retrospective study of corneal transplatation
Scientific Title	Retrospective study of corneal transplatation
Scientific Title:Acronym	Retrospective study of corneal transplatation
Region	Japan

Condition
Condition	Post corneal graft transplantation eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of post operative status of corneal transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneal graft survival
Key secondary outcomes	Visual acuity, Corneal endothelial density, Central corneal thickness

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Post corneal transplantation
Key exclusion criteria	Patients who disagree to be involved in the study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Wakimasu
Organization	Baptist Eye Yamasaki Clinic
Division name	Ophthalmology
Zip code	606-8287
Address	12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL	075-721-3800
Email	kwakimas@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Wakimasu
Organization	Baptist Eye Yamasaki Clinic
Division name	Ophthalmology
Zip code	606-8287
Address	12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL	075-721-3800
Homepage URL
Email	kwakimas@koto.kpu-m.ac.jp

Sponsor
Institute	Baptist Eye Yamasaki Clinic
Institute
Department

Funding Source
Organization	Baptist Eye Yamasaki Clinic
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	Baptist Eye Yamasaki Clinic
Address	12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
Tel	075-721-3800
Email	secret@eye-clinic.gr.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	2016 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2012 Year 05 Month 18 Day
Date of IRB	2012 Year 05 Month 18 Day
Anticipated trial start date	2012 Year 05 Month 18 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024351