UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation
Title of the study (Brief title)	Exploratory clinical trial of artificial cornea Boston keratoprosthesis
Region	Japan

Condition
Condition	Refractory corneal opacity
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical efficacy and safety of artificial cornea Boston keratoprosthesis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy: visual acuity Safety: Ratio of KPro survival
Key secondary outcomes	Complications, Adverse effects

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	Device,equipment
Interventions/Control_1	Transplantation of Boston KPro
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Eyes after corneal transplant failure over twice in which unsuccessful corneal transplant is expected. 2) Best corrected visual acuity less than 0.05 and visual acuity in the contralateral eye is decreased. 3) Age of 20 years or more. 4) Patients giving informed consent with documents.
Key exclusion criteria	1) End-stage glaucoma 2) Eyes with retinal detachment or optic disc atrophy. 3) Patients with auto-immune disease(pemphigoid, Stevens-Johnson syndrome, uveitis, Sjogren syndrome),after chemical burn, or severe inflammatory disease. 4) Eyes with incomplete blinking or insufficient tearing. 5) Patients who cannot receive frequent postoperative examination. 6) Pregnant women or women who are expected to be pregnant. 7) Breast-feeding women 8) Patients doctors did not think are appropriate for this study.
Target sample size	6

Research contact person
Name of lead principal investigator	Tomohiko Usui
Organization	University of Tokyo
Division name	Department of Ophthalmology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5800-8660
Email	tomohiko-tky@umin.ac.jp

Public contact
Name of contact person	Tomohiko Usui
Organization	University of Tokyo
Division name	Department of Ophthalmology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-5800-8660
Homepage URL
Email	tomohiko-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Department of Ophthalmology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	東京大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 20 Day
Anticipated trial start date	2011 Year 06 Month 01 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 01 Month 13 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008321