UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Title of the study (Brief title)	Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Region	Japan

Condition
Condition	Bullous keratopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	corneal thickness after surgery
Key secondary outcomes	visual acuity, survival of the graft, corneal endothelial cell density, success in DMEK graft preparation, success in the graft transplantation, complication

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Descemet membrane endothelial 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Bullous keratopathy patients who are indicated for Endothelial Keratoplasty in Osaka University Hospital 2)Aged 20 years old and over 3)Written informed consent
Key exclusion criteria	1)Bullous keratopathy patients who are not indicated for Endothelial Keratoplasty 2)Those who have been decided not appropriate for enrollment by the principal investigator. 3)Patients of less than 6 months follow-up period.
Target sample size	10

Research contact person
Name of lead principal investigator	Kohji Nishida
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3451
Email	knishida@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person	Takeshi Soma
Organization	Osaka University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3456
Homepage URL
Email	soma@ophthal.med.osaka-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 09 Day
Anticipated trial start date	2014 Year 06 Month 12 Day
Last follow-up date
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	2014 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016591